Comphya has closed an oversubscribed Series A round that brings its total equity raised to CHF 7.5 million (approximately $8.4 million). The company earmarked the funds to advance clinical programs for CaverSTIM, an implantable neurostimulation system intended for men with erectile dysfunction that does not respond to medication. Proceeds will launch and run a U.S. […]
About Danielle Kirsh
Integer appoints former iRhythm CEO to board
Integer Holdings has appointed Michael Coyle to its board of directors and assigned him to the audit, compensation and technology strategy committees. Coyle brings more than 40 years of industry experience. He most recently served as president and CEO of iRhythm Technologies and earlier led Medtronic’s cardio and vascular group. Previous roles include leadership positions […]
Aurora Spine begins first procedures with Aero lumbar fusion system
Aurora Spine today announced surgeons have performed the first procedures using the company’s Aero Lumbar Fusion System. The two initial lumbar surgeries were performed by separate physicians, one an orthopedic surgeon and the other an interventionalist, the company said. The Aero MIS Lumbar Fusion System is cleared for spinal levels C2 to S1 inclusive. It […]
Mendaera wins FDA clearance for robotic needle placement
Mendaera has received FDA 510(k) clearance for its Focalist handheld robotic system, which enhances the precision of ultrasound-guided needle placement across multiple specialties. The San Mateo, California-based company said Focalist combines handheld robotics, real-time ultrasound imaging and software that supports touchscreen targeting, robotic needle positioning and continuous depth-tracking. Mendaera plans a limited launch with select […]
Former Masimo COO is joining BD to run Connected Care
BD has appointed Bilal Muhsin executive vice president and president of its future Connected Care segment, effective immediately. Muhsin will join the BD executive leadership team and report to CEO and President Tom Polen. He will guide strategy development as the company transitions to the new structure announced under its New BD strategy. BD Connected […]
Merit Medical is getting a new CEO
Merit Medical Systems (Nasdaq:MMSI) has appointed Martha Aronson as its next president and CEO, effective Oct. 3, 2025. Founder Fred Lampropoulos will remain chair of the board after he steps down as CEO on the same date. The company’s former president, Joseph Wright, resigned in December 2024. The South Jordan, Utah–based company makes and distributes […]
Pristine Surgical appoints new CFO
Pristine Surgical today announced it appointed Susan O’Shea as chief financial officer, effective immediately. O’Shea has more than two decades of financial leadership experience in regulated, high-growth environments, the Manchester, N.H.-based company said. She will be responsible for leading Pristine’s financial strategy, capital formation, and operational infrastructure. “Susan is exactly the kind of leader we […]
Philips wins FDA clearance for AI MRI software SmartSpeed Precise
Philips has announced it received FDA 510(k) clearance for its deep-learning reconstruction tool, SmartSpeed Precise. SmartSpeed Precise can scan up to three times faster and produce images up to 80% sharper than earlier methods. The technology is now cleared for clinical use on all Philips 1.5-tesla and 3-tesla MRI systems, including the existing installed base. […]
Moon Surgical wins two FDA clearances for Maestro surgical robot
Moon Surgical today announced it received FDA 510(k) clearance for two new features on the Maestro robotic surgical assistant. The clearances cover connectivity of the platform to power the Maestro Insights product and a Predetermined Change Control Plan (PCCP) to evolve its AI-powered ScoPilot product. Maestro can now use active Wi-Fi and 5G connectivity, allowing […]
Inner Cosmos brings Intuitive co-founder onto board
Inner Cosmos has added John Freund to its board of directors and appointed Greg Schulte as advisory chief technology officer as the company moves its “Digital Pill” brain-computer interface (BCI) through clinical trials. “The appointments of John and Greg strengthen our leadership bench as we move through clinical trials and prepare for what we hope […]
STENTiT enrolls first patient in trial of regenerative stent system
STENTiT has implanted its Resorbable Fibrillated Scaffold in the first patient enrolled in the VITAL-IT 1 study evaluating the device for chronic limb-threatening ischemia (CLTI) below the knee. The prospective, non-randomized feasibility study will enroll up to 10 patients at the Medical University of Graz in Austria and follow them for 24 months. Investigators used […]
