Medical Devices & Technology

Lexington, S.C. – September 14, 2026 -- ElectroWire Medical's FDA-cleared LightningWire Transseptal Puncture System has completed its first six clinical cases at Spartanburg Medical Center in Spartanburg, South Carolina, with zero complications reported.

Six procedures spanned mitral repair, LAA occlusion and pulsed field ablation

The case mix included one mitral valve repair, one left atrial appendage occlusion, and four pulsed field ablations, performed by structural interventional cardiologist Dr. Nalin Srivastava and cardiac electrophysiologist Dr. David Rodak. The team used four different transseptal introducers and two different electrosurgical generators during the cases, testing the device's compatibility with equipment already in operator inventories.

Dublin – – September 13, 2026 -- LUMA Vision has secured an expanded FDA clearance for VERAFEYE, its procedural intelligence platform for minimally invasive cardiac procedures, moving the company closer to a planned commercial launch in early 2027.

VERAFEYE now unifies digital anatomy creation, catheter tracking, and guidance on a single platform

The new clearance allows VERAFEYE to reconstruct 3D models of the left and right atria with CT-like accuracy using a single 360° imaging catheter that captures raw ultrasound data. The platform lets physicians visualize and document ablation delivery directly on the anatomy while maintaining continuous tracking of both imaging and ablation catheters through electromagnetic tracking and automated imaging.

San Francisco – September 13, 2026 -- Cionic reported that the first 60 participants in its TRANSFORM study showed an average 26% improvement in health-related quality of life after one month, using the standardized EQ-5D-5L instrument across all five measured dimensions.

Cionic launches 12-month study tracking 1,000 adults with upper motor neuron conditions

The TRANSFORM study follows 1,000 adults with multiple sclerosis, stroke, spinal cord injury, cerebral palsy, and related conditions over 12 months, collecting quality-of-life data through six surveys administered via the Cionic mobile app at onboarding and at one, three, six, nine, and 12 months. The primary endpoint, EQ-5D-5L, measures mobility, self-care, usual activities, pain, and anxiety/depression, while secondary measures track spasticity, urinary incontinence, and fatigue.

Warsaw, Ind. – September 13, 2026 -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) named three internal executives to newly restructured president roles effective October 1, as Group President Kevin Thornal exits the company on September 30 following a transition period.

Gary Campbell takes over commercial strategy across the Americas

Campbell, promoted to President, Americas, will oversee commercial execution in the United States, Canada and Latin America. He has served as vice president and general manager, Orthopedics – North America, since September 2024, and joined Zimmer Biomet in 2019 after prior sales and marketing roles at Enovis.

Grand Rapids, Mich. – – September 13, 2026 -- Shoulder Innovations, Inc. (NYSE: SI) has settled all outstanding patent litigation with Catalyst OrthoScience Inc., ending a legal dispute between the two shoulder-implant makers under confidential terms.

Shoulder Innovations resolves patent dispute with Catalyst OrthoScience under sealed terms

The settlement agreement closes all pending patent claims between Shoulder Innovations and Catalyst OrthoScience without disclosing financial or licensing terms.

CEO Rob Ball says the deal protects intellectual property tied to shoulder arthroplasty innovation

"We are pleased to have reached a resolution with Catalyst that provides an agreeable solution to this patent dispute," said Rob Ball, CEO of Shoulder Innovations. He said protecting intellectual property remains fundamental to ensuring continued investment benefits stakeholders, including surgeons and patients.

Danbury, Conn. – September 12, 2026 -- Perosphere Technologies Inc. announced that a clinical study evaluating its ClotChek point-of-care coagulometer has been published in the peer-reviewed journal Thrombosis and Haemostasis, confirming the device's ability to detect anticoagulation levels in patients on Factor Xa inhibitors apixaban and rivaroxaban.

Study confirms ClotChek detects DOAC anticoagulation at two clinical thresholds

The research measured ClotChek Clotting Time (CKCT) against anti-FXa drug levels in patients on direct oral anticoagulants, finding strong correlations when categorized by Medical Decision Limits. The device demonstrated the ability to identify clinically meaningful anticoagulation at both the >75 ng/mL and >30 ng/mL thresholds, including sensitivity at lower drug concentrations.

Stockholm – September 12, 2026 -- SciBase Holding AB (STO: SCIB) has received an additional order worth roughly $0.6 million, or approximately SEK 5 million, from Castle Biosciences (NASDAQ: CSTL) to accelerate an ongoing clinical study and prepare a second trial under their dermatology collaboration.

Order covers Nevisense Go devices and electrodes for atopic dermatitis research

The order includes both SciBase's portable Nevisense Go pen device and associated electrodes. Deliveries are scheduled to begin in the fourth quarter of 2026.

Collaboration targets relapse prediction in atopic dermatitis patients

SciBase and Castle Biosciences entered a collaboration and license agreement in 2025. The first joint study under that agreement aims to predict relapses in atopic dermatitis and is currently underway, with the new order funding both faster progression of that trial and groundwork for a follow-up study.

Haifa/Frankfurt – September 11, 2026 -- Insightec has treated 10,000 patients across Europe, the Middle East and Africa with its Exablate Neuro platform for essential tremor and Parkinson's disease, a figure that has more than doubled over the past three years. The incisionless MR-guided focused ultrasound (MRgFUS) therapy is now available at more than 62 treatment centers in 20 countries across the region, part of a global network exceeding 30,000 patients treated at 226 centers worldwide.

Treatment volumes double in three years as adoption accelerates

The EMEA milestone caps a decade of expansion for focused ultrasound in the region, with hospitals increasingly offering the incisionless approach to patients whose only prior options were medication or invasive surgery. Growth spans both essential tremor and Parkinson's disease indications, according to Jake Ghannam, Executive Vice President and Chief Commercial Officer at Insightec.

Freiburg – – September 11, 2026 -- Intuitive Surgical has secured CE marking for Force Feedback instruments on its da Vinci 5 surgical system, clearing the technology for use across the European market alongside more than 100 additional system updates.

Force Feedback lets surgeons feel tissue resistance in real time

The instruments capture pressure, traction and lateral forces roughly 1,000 times per second, relaying them directly through the hand controllers on the da Vinci 5 console. A real-time force gauge, resembling a speedometer, displays the intensity of force applied to tissue during a procedure. Post-operatively, surgeons can review force data through Case Insights in the MyIntuitive+ platform to refine technique and reduce variability between cases.

Los Angeles – – September 11, 2026 -- Schall, Brown & Schwartz LLP has filed a federal securities class action against Beta Bionics, Inc. (NASDAQ: BBNX), alleging the company misled investors about FDA findings tied to its iLet Bionic Pancreas insulin pump. The case, Holtzman v. Beta Bionics, Inc. et al., No. 2:26-cv-09999, is pending in the U.S. District Court for the Central District of California.

Class period spans July 2025 to February 2026 amid disputed FDA findings

The class covers purchasers of Beta Bionics common stock between September 11, 2026 and September 11, 2026. Investors face a September 11, 2026 deadline to seek appointment as lead plaintiff.