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MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Danielle Kirsh

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

Comphya raises CHF 7.5 million for neurostim to treat ED

July 11, 2025 By Danielle Kirsh

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. […]

Filed Under: Business/Financial News, Funding Roundup, Neuromodulation/Neurostimulation Tagged With: Comphya

Integer appoints former iRhythm CEO to board

July 11, 2025 By Danielle Kirsh

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 […]

Filed Under: Business/Financial News, Contract Manufacturing Tagged With: integer, Personnel Moves

Aurora Spine begins first procedures with Aero lumbar fusion system

July 9, 2025 By Danielle Kirsh

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 […]

Filed Under: Orthopedics Tagged With: Aurora Spine

Mendaera wins FDA clearance for robotic needle placement

July 8, 2025 By Danielle Kirsh

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 […]

Filed Under: 510(k), Diagnostics, Food & Drug Administration (FDA), Imaging, Oncology, Regulatory/Compliance, Robotic-Assisted, Surgical, Ultrasound Tagged With: Mendaera

Former Masimo COO is joining BD to run Connected Care

July 8, 2025 By Danielle Kirsh

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 […]

Filed Under: Business/Financial News, Digital Health, Featured Tagged With: BD, Personnel Moves

Merit Medical is getting a new CEO

July 8, 2025 By Danielle Kirsh

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 […]

Filed Under: Business/Financial News, Featured, Oncology Tagged With: Merit Medical Systems, Personnel Moves

Pristine Surgical appoints new CFO

July 7, 2025 By Danielle Kirsh

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 […]

Filed Under: Business/Financial News, Catheters Tagged With: Personnel Moves, Pristine Surgical

Philips wins FDA clearance for AI MRI software SmartSpeed Precise

July 2, 2025 By Danielle Kirsh

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. […]

Filed Under: 510(k), Business/Financial News, Food & Drug Administration (FDA), Imaging, Mammography, Regulatory/Compliance Tagged With: Philips

Moon Surgical wins two FDA clearances for Maestro surgical robot

July 2, 2025 By Danielle Kirsh

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Surgical Robotics Tagged With: Moon Surgical

Inner Cosmos brings Intuitive co-founder onto board

July 1, 2025 By Danielle Kirsh

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 […]

Filed Under: Brain-Computer Interface (BCI), Business/Financial News, Clinical Trials, Neuromodulation/Neurostimulation Tagged With: Inner Cosmos, Personnel Moves

STENTiT enrolls first patient in trial of regenerative stent system

June 27, 2025 By Danielle Kirsh

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 […]

Filed Under: Business/Financial News, Cardiovascular, Clinical Trials, Featured, Stents, Vascular Tagged With: STENTiT

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