Tivic Health's successful pricing of a $2.1 million offering reflects investor confidence in the company's innovative medical device solutions. The offering comes just days after the company closed another $1.8 million offering of common stock. Fast Five hosts Sean Whooley and Danielle Kirsh discuss what the offer includes and when it will close. 

The collaboration between Glaukos and Radius XR signifies the growing adoption of wearable diagnostics in ophthalmology, aiming to improve disease monitoring and personalized patient care. Hear more about the wearable diagnostic platform and the terms of the collaboration agreement. 

IR-MED recently announced positive interim results from a clinical study of its PressureSafe noninvasive, handheld optical monitoring device. Whooley gives an inside look at some of the key findings of the study, as well as what the device does.

Philips initiated a repurchasing program to cover certain obligations arising from long-term incentive plans. Learn about how much money is involved in the program and the timelines associated with it.

The adoption of the Asensus surgical robot platform by a leading U.S. hospital for pediatric procedures showcases the expanding application of robotic-assisted surgery in specialized areas of medicine. Kirsh and Whooley discuss the surgical robotic platform and what makes it compatible with pediatric patients.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Boston Scientific received FDA approval for image-guided programming software, advancing deep brain stimulation treatments for neurological conditions. Fast Five hosts Sean Whooley and Danielle Kirsh review what the software offers clinicians.

Henry Schein recently secured a $750 million credit facility, fueling its growth and ability to provide quality products and services in the medical device industry. Learn about the credit facility's maturity, what executives are saying, and some of the busy strategic moves the company made earlier this week.

Aerin Medical's treatment for nasal airway obstruction gained support with data validation, offering effective solutions for improved breathing and quality of life. Whooley and Kirsh discuss what VivAer is and some of the key data points from the study and what doctors think of the device. 

Inogen recently expanded its respiratory care portfolio by acquiring Physio-Assist, a French developer of airway clearance technology. Hear about Physio-Assist's business and what Inogen's rationale was behind the acquisition. 

BD highlighted the importance of medical device cybersecurity, disclosing and addressing eight vulnerabilities in the Alaris infusion systems. The Fast Five hosts explain which devices are included in the vulnerabilities and the rocky history of Alaris pumps in the last few years.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Olympus this week announced positive study data for its minimally invasive iTind treatment for enlarged prostate symptoms. Fast Five hosts Sean Whooley and Danielle Kirsh go over what that treatment option is, how it works and what some of the study results showed. 

Eitan Medical's launch of a cloud-based infusion management platform reflects the integration of digital technologies into healthcare, aiming to enhance patient safety and optimize medication administration. Learn more about what Eitan Insights is and what the company designed the technology for in today's episode. 

Urotronic designed Optilume as a minimally invasive surgical therapy to alleviate urinary symptoms caused by BPH – and the FDA approved its use this week. Whooley explains what the technology does and how optimistic executives are after news of the approval. 

FDA's updated guidance on paclitaxel-coated devices provides important insights into the ongoing evaluation and monitoring of device safety. Hear about why it updated the guidance and the recommendations for provider action with the new guidance. 

The EU's significant fine imposed on Illumina over the Grail deal highlights the increasing scrutiny and regulation within the medtech industry, particularly regarding mergers and acquisitions. Whooley and Kirsh discuss why the fine was issued, as well as a brief history of the acquisition and what Illumina plans to do next.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Heart failure is a prevalent condition that requires effective management and monitoring to improve patient outcomes and quality of life. Shifamed portfolio company Adona Medical recently introduced its next-generation heart failure platform. Fast Five hosts Sean Whooley and Danielle Kirsh detail the technology that is featured in the system and how it works to enhance patient care.

The FDA clearance of Tandem Diabetes Care's Mobi durable automated insulin pump reflects the ongoing advancements in diabetes management and the integration of technology into treatment options. Learn how Tandem's new technology differs from its existing platforms and how it stacks up against other competitors already on the market.

Stryker announced this week that it launched its Q Guidance System with cranial guidance software. This launch comes on the heels of last week’s Ortho Q fully autonomous guidance system launch. In today's episode, Whooley explains what the system is designed for and some of the technology behind the guidance software.

ECG interpretation software can assist healthcare professionals in analyzing electrocardiogram results, potentially aiding in detecting and diagnosing cardiac abnormalities. The FDA cleared AccurKardia's ECG interpretation software just this week. Hear about the features and benefits of the system and the clinical data that support its use in this episode.

The FDA labeled a recall of Megadyne electrode products manufactured by Johnson & Johnson’s Ethicon Class I, the most serious kind. Whooley and Kirsh discuss the reason behind the recall, how many devices are affected and if there have been reports of injury from use of the devices.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

The FDA clearance of Getinge's non-invasive mechanical ventilator showcases the ongoing efforts to develop advanced respiratory devices that can provide critical support to patients in need. Fast Five hosts Sean Whooley and Danielle Kirsh detail what the ventilator does and when patients can expect the ventilators to hit the market.

PainTEQ's successful fundraising round will expand the commercialization of its LinQ implantable sacroiliac (SI) joint stabilization system. Whooley explains the technology behind the device and the company's success in previous procedures using the device.

Chief financial officers play a crucial role in driving financial strategies, ensuring regulatory compliance, and supporting business growth and sustainability, and Fresenius Medical Care appointed a new one to its executive team. Hear how the appointee's career history supports their appointment and how optimistic executives are in today's episode. 

The U.S. Federal Trade Commission wants to have a say in Applied Medical Resources’ antitrust lawsuit against Medtronic. Whooley and Kirsh discuss the ongoing lawsuit, why Medtronic wants to dismiss the lawsuit and what the FTC has to say about it.

The decline in Outset Medical's stock following the receipt of an FDA warning letter demonstrates the impact that regulatory compliance and product quality have on investor confidence. The Fast Five hosts discuss the details in the warning letter and if it will affect Outset Medical's production of devices.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Microbot Medical's completion of a pre-clinical study for its endovascular surgical robot signifies a significant milestone for the company. Fast Five hosts Danielle Kirsh and Sean Whooley explain what the surgical robot does and what the outcome of the pre-clinical study was.

The FDA clearance of Boston Scientific's Embold Soft & Packing coils demonstrates the company's commitment to expanding its portfolio of innovative solutions for embolization procedures. Hear about what the coils are designed for and how it streamlines hospital workflows on today's episode.

Integra Lifesciences' completion of enrollment in the DuraSorb monofilament mesh IDE study is a significant step toward gathering valuable clinical data for this product. Whooley details what the study will evaluate and how optimistic are executives at the company.

Federal prosecutors claim a former DePuy Synthes sales representative defrauded an undisclosed Boston area hospital, with hundreds of thousands of dollars worth of spine products involved. Kirsh and Whooley share what the sales representative is accused of, how it allegedly benefitted the sales rep and DePuy Synthes' response. 

The resignation of NeuroPace's CEO and the appointment of a former Integer executive as his successor mark a significant leadership change within the company. Whooley and Kirsh discuss the details behind the resignation and who is taking over the corner office.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

A study demonstrating the health equity impact of Virta Health's diabetes reversal platform highlights the potential of digital health solutions in addressing disparities in healthcare outcomes. Fast Five hosts Sean Whooley and Danielle Kirsh go over the critical points of the study and who the company found is most affected by diabetes.

BioSig's expansion of research and development efforts in machine learning and artificial intelligence (AI) for cardiac arrhythmia treatment signifies the growing role of AI in improving patient care. Whooley details what the company plans to use AI for and how optimistic executives are.

Medline recently announced that it is promoting from within to fill the CEO and president positions opening up at the privately-held medtech giant. Hear who is taking over the corner office and how this transition could be crucial in shaping the company's future. 

Carthera's successful Series B funding round, raising $40M, underscores the growing interest and investment in innovative therapies for neuro-oncology. The Fast Five hosts discuss the technology driving the funding round and its potential applications.

Masimo's loss of board seats to activist investor Politan suggests a potential shift in the company's governance and strategic direction. Learn about Masimo's response and what investors think the next step should be for Masimo in today's episode.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Sernova's positive interim data for the Cell Pouch System highlights the potential of regenerative medicine in addressing various medical conditions. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the key findings in the data in today's episode.

Ultra-low frequency neuromodulation has the potential to revolutionize the field by offering more precise and targeted treatment options. Presidio Medical recently raised $72 million for its ultra-low frequency neuromodulation, and Whooley has all the details on the fundraising.

Augmedics' successful funding round and milestone of treating 4,000 U.S. patients with Xvision underscore the growing adoption and impact of augmented reality (AR) in surgical procedures. Hear how the Xvision technology works and why this was a significant capital raise.

Teleflex issued a Class I recall of its Arrow Endurance extended dwell peripheral catheter system. The Fast Five hosts provide more details about how many devices are affected and how many complaints there have been so far.

Boston Scientific elected Dr. Jessica Mega and Susan Morano to its board of directors. Whooley and Kirsh explore the appointees' career backgrounds and what CEO Mike Mahoney said about the appointments.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Continuous glucose monitoring (CGM) systems have revolutionized diabetes management by providing real-time data on glucose levels, and new data supports the safety and accuracy of Senseonics 365-day CGM. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the study's key findings.

Aortic aneurysms pose significant health risks. The FDA's approval of Cook Medical's endovascular graft trial represents a positive development in treating this condition. Hear how Cook Medical wants to make the gold-standard treatment of aortic aneurysms easier. 

Diabetes management is not limited to insulin users alone, and Dexcom's endeavor to develop a glucose sensor for non-insulin users reflects a commitment to inclusivity. Whooley explains what the technology will cover and how Medicare will cover the innovation.

Medtronic's appointment of Greg Lewis as director adds another seasoned professional with extensive financial experience to the company's leadership team. The Fast Five hosts detail his prior experience and CEO Geoff Martha's thoughts.

Mergers and acquisitions are common in the medical device industry as companies seek to enhance their product portfolios. Whooley and Kirsh outline Restor3d's plan to acquire Conformis, including when the transaction is expected to close and what executives at both companies are thinking.

Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast.

Teleflex's voluntary recall of its Rüsch endotracheal tubes highlights the possibility of oxygen desaturation, and in the event, any immediate or long-term health consequences depend on the degree and duration of desaturation. Fast Five hosts Sean Whooley and Danielle Kirsh share what issue caused the recall and how many complaints the company has received so far.

The FDA's IDE approval of Metavention's renal denervation therapy represents an important milestone in the treatment of hypertension. Whooley details what the platform does, how it works and how optimistic executives are.

Real-world data validating the efficacy and usability of Bigfoot Biomedical's diabetes management platform underscores its potential to revolutionize diabetes care. Kirsh and Whooley discuss some of the key data points from the study and the company's future plans.

Insulet's ongoing efforts to integrate its Omnipod 5 system with Abbott's FreeStyle Libre 2 sensor marks a significant advancement in the company's diabetes management technology. Whooley talks about where the technology is currently integrated and plans for a clinical study in the future.

The appointment of Lea Daniels Knight as CFO of Integra Lifesciences brings a seasoned financial leader to the company's executive team. Hear about her prior experience in finance and medtech and what the company's CEO has to say.

Check out the show notes for links to the stories we discussed and more at MassDevice.com/podcast.