Onward Medical announced today that the FDA accepted it into its new Total Product Lifecycle Advisory Program (TAP) — a move that could boost the development of Onward’s BCI technology. Acceptance into the TAP program comes on the heels of FDA breakthrough device designation for the ARC-BCI system last month. Breakthrough device designation is a […]
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FDA clears pulsed field ablation electrode tech from Pulse Biosciences
Pulse Biosciences (Nasdaq:PLSE) announced that the FDA granted 510(k) clearance for its CellFX nsPFA percutaneous electrode system. The Hayward, California-based company develops the CellFX nanosecond pulsed field ablation (nsPFA) system. Its percutaneous electrode system enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures. CellFX nsPFA’s percutaneous electrode system features a percutaneous needle […]
iRhythm closes offering worth more than $660M
iRhythm announced today that it closed an offering of senior notes worth gross proceeds of $661.25 million. The San Francisco-based cardiac monitor maker said earlier this week that it intends to offer $450 million in convertible senior notes. Approximately 17 hours later, it upsized that offering to a base of $575 million. San Francisco–based iRhythm […]
Karl Storz launches surgical education tech for Apple Vision Pro
Karl Storz announced that it released the CollaboratOR 3D app for Apple Vision Pro to provide immersive surgical education. This marks yet another medtech application on Apple’s VR headset, with Siemens Healthineers and Stryker recently unveiling similar offerings. Karl Storz designed its application in tandem with software developer T1V to complement the functionality of OR1, […]
Fast Five: FTC may look at Boston Scientific’s Axonics buy, Roche unveils new AI-enabled CGM
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, March 8, 2024. Fast Five by MassDevice · Fast Five: FTC may look at Boston Scientific’s Axonics buy, Roche unveils new AI-enabled CGM Siemens Healthineers […]
Siemens Healthineers launches surgical planning app on Apple Vision Pro
Siemens Healthineers announced that it launched an app for surgical planning and medical education on the Apple Vision Pro. The Cinematic Reality app enables users to view immersive, interactive holograms of the human body captured through real-world medical scans. Surgeons, medical students or patients could use this technology. Visualizing through the app could assist in […]
Roche unveils new CGM tech with predictive AI, outlines diabetes strategy
Roche today gave a presentation debuting its first continuous glucose monitor (CGM) offering that utilizes predictive AI. The company unveiled its Accu-Chek SmartGuide in an event at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Florence, Italy. It remains an investigational device not yet authorized for sale. Julien Boisdron, Roche Diabetes Care’s chief medical […]
FTC reportedly may scrutinize Boston Scientific’s Axonics deal
Bloomberg reports that the U.S. Federal Trade Commission (FTC) may look into the $3.7 billion acquisition of Axonics (Nasdaq:AXNX) by Boston Scientific . A new Axonics regulatory filing with the SEC discloses that the companies refiled their Hart Scott Rodino (HSR) Act notification to the FTC on March 4 — a move that companies sometimes […]
Fast Five: Dexcom gets first OTC CGM nod from FDA, ResMed launches new mask
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, March 7, 2024. Fast Five by MassDevice · Fast Five: Dexcom gets first OTC CGM nod from FDA, ResMed launches new mask Abbott reported some […]
Real-world data backs Abbott FreeStyle Libre CGM in tandem with GLP-1s
Abbott today announced data from two real-world studies highlighting the success of its CGM when used with GLP-1 drugs. Data showed that people with type 2 diabetes using GLP-1s with FreeStyle Libre had a greater improvement in HbA1c compared to GLP-1s alone. Abbott presented the findings at the Advanced Technologies & Treatments for Diabetes (ATTD) […]
ResMed launches new sleep apnea mask
ResMed announced today that it launched the AirFit F40 ultra-compact, full-face mask for sleep apnea. San Diego-based ResMed designed AirFit F40 to offer the comfort of smaller masks without sacrificing performance. This could, in turn, help with sleep apnea therapy compliance for users of high-pressure continuous positive airway pressure (CPAP) treatment. According to a news […]