Analysts from Bank of America predict a favorable environment for mergers and acquisitions in the medtech space in 2025. Travis Steed, Stephanie Piazzola, Craig Bijou and Enjia Cao say 2024 was “a typical year” in terms of M&A in medtech. They tracked 19 acquisitions of note with around $25 billion in disclosed deal price. Some […]
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SetPoint Medical submits neuromod device to FDA
SetPoint Medical announced today that it filed with the FDA for premarket approval (PMA) of its neuroimmune modulation device. The Valencia, California-based company develops the system as a potential first-of-its-kind treatment for moderate-to-severe rheumatoid arthritis (RA). Its target population are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). SetPoint designed […]
AngioDynamics wins FDA clearance for NanoKnife system in prostate tissue ablation
AngioDynamics today announced it received FDA 510(k) clearance for its NanoKnife system for prostate tissue ablation in patients with intermediate-risk prostate cancer. The clearance follows the company’s completion of the pivotal PRESERVE clinical study, which enrolled 121 patients across 17 sites and was completed in collaboration with the Society of Urologic Oncology Clinical Trials Consortium. […]
InspireMD begins pivotal study of CGuard Prime in TCAR procedures
InspireMD today announced it enrolled the first patient in its CGUARDIANS II pivotal study, which will evaluate the CGuard Prime Carotid Stent System in trans carotid artery revascularization (TCAR) procedures. The first patient was enrolled at Good Samaritan Hospital in Cincinnati, Ohio, by Dr. Patrick Muck, who is the co-lead investigator for the study. CGUARDIANS […]
Anteris Technologies launches IPO to support heart valve technology
Anteris Technologies today announced the launch of its initial public offering in the U.S. The company aims to raise funds through the IPO to advance the development of its DurAVR transcatheter heart valve technology. Anteris’ IPO consists of 14.8 million shares of common stock, with an additional 2.22 million shares available to underwriters under a […]
Stereotaxis wins approval in China for magnetic ablation catheter
Stereotaxis (NYSE:STXS) announced today that its Magbot magnetic navigation ablation catheter received regulatory approval in China. This nod comes just weeks after the company won approval from China’s National Medical Products Administration for the Genesis robotic magnetic navigation (RNM) system. St. Louis, Missouri-based Stereotaxis aims to accelerate access to its minimally invasive technology in China. […]
Cala Health raises $50M growth round
Cala Health announced today that it raised a $50 million growth financing round to support its TAPS therapy. Vertex Growth Fund and Nexus NeuroTech Ventures co-led the financing round. All existing investors, including Action Potential, Johnson & Johnson, Lightstone, Lux, GV (Google Ventures), OSF Ventures, Ascension Ventures, TriVentures, Reimagined Ventures, Peak6 and Fiscus also participated. […]
Vicarious Surgical CFO departs, surgical robot timeline is unchanged
Vicarious Surgical (NYSE:RBOT) announced that CFO William Kelly plans to leave the company to pursue other career opportunities. Kelly joined the Waltham, Massachusetts-based company as CFO in January 2021. About four years later, Kelly expects to depart on Jan. 2, 2025. He plans to assist the company to ensure minimal disruption and a successful transition […]
Layoffs in medtech: These companies recently reduced their workforce
Medtech layoffs are picking up as 2024 draws to a close. Sean Whooley, Associate Editor, and Chris Newmarker, Editor-in-Chief The medical device industry is closing out the year with a fresh round of layoffs. At this point, MassDevice has reported on more than 22,000 medtech job cuts across the industry since mid-2022. (Have a tip […]
Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system
Lungpacer Medical announced that it received FDA premarket approval for its flagship AeroPace neurostimulation system. AeroPace uses neurostimulation via an electrode-containing cardiovascular catheter and a software-controlled system. It delivers periodic phrenic nerve stimulation through the venous catheter. The system contracts and strengthens the diaphragm in patients on mechanical ventilation. Exton, Pennsylvania–based Lungpacer’s system received an […]
Profound Medical prices $35M offering
Profound Medical (Nasdaq:PROF) announced today that it priced an underwritten public offering worth proceeds of approximately $35 million. Toronto-based Profound is offering nearly 4.7 million shares of common stock at $7.50 per share. The company also granted underwriters a 30-day option to purchase up to an additional 700,005 common stock shares at the public offering […]