Garmin Navigates into ECG Space
Garmin, once known for its GPS systems, is the latest tech company to enter the ECG space. FDA cleared the Garmin ECG app, which is designed to allow users to record their heart rhythm and check for signs of atrial fibrillation or normal sinus rhythm. The app is available on the Venu 2 Plus smartwatch. When customers take an ECG, the app uses sensors on the Venu 2 Plus to record the electrical signals that control how their heart beats. The app then analyzes the recording.
Intuitive Dashes Hopes for a 2023 Catalyst
Expectations for a next-gen multiport robotic system from Intuitive Surgical have been building for multiple quarters. But instead of confirming expectations, Intuitive told investors last week that a next-generation multiport system will not be launched in 2023. The news left analysts scratching their heads and tanked the company's shares.
Not Even J&J Is Exempt from Macroeconomic Woes
Johnson & Johnson expects its operational growth in medtech during the first half of 2023 to be lower than the second half of the year. The sluggish first-half guidance is due to ongoing procedure volume recovery, a lingering COVID-19 impact in China, and ramping of new product launches.
And in case you missed our last Medtech in a Minute report...
Surmodics Takes a Regulatory Punch to the Gut
Surmodics has traveled a long road to bring its SurVeil drug-coated balloon (DCB) to the U.S. market, and that road just got considerably longer. The company received an FDA letter this week that its premarket approval (PMA) application is not currently approvable. The agency wants to see additional information regarding the biocompatibility of the device and the labeling, which would require additional testing and analysis. The silver lining is that the agency did not question the human clinical data submitted, nor did it ask for additional clinical data.
Medtech M&A Activity Picks Up
Shockwave, Baush + Lomb, and Bayer all announced acquisitions this week. Shockwave agreed to buy Neovasc for about $100 million plus up to $47 million in milestone payments tied to regulatory achievement. Baush + Lomb said an affiliate has acquired AcuFocus, a company that has developed small aperture intraocular technology to address the diverse unmet needs in eye care. Bayer announced the acquisition of Blackford Analysis, a global strategic imaging AI platform and solutions provider. Neither Baush + Lomb nor Bayer disclosed financial terms of their respective deals.
Layoffs Hit Medtech Hard
PAVmed and its subsidiaries joined the growing list of medtech companies that are slashing workforces in 2023. The company is cutting 20% of its workforces. The news follows on the heels of Verily cutting 15% from its payroll. Earlier this month, Motus GI axed 45% of its workforce and said it would explore financial alternatives.