EndoStim announced that it received FDA breakthrough device designation for its neurostimulation system for treating GERD. Santa Ana, California-based EndoStim designed its system to treat drug-refractory gastroesophageal reflux disease (GERD). The disease affects the ring of muscle between the esophagus and the stomach, the lower esophageal sphincter (LES). It causes stomach acid to repeatedly flow […]
FDA
FDA proposes updates to Breakthrough Devices Program guidance
Emergo by UL The U.S. Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance. Once finalized, the guidance document updates would expand the Breakthrough Devices Program’s scope to include devices that will improve accessibility and promote health equity. Specifically, the draft guidance clarifies the considerations […]
What does the future hold for AI in medical devices?
Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world. Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control […]
Abiomed reaches new regulatory milestone for its Impella pumps
Abiomed (Nasdaq:ABMD) announced that the FDA accepted and closed its post-approval study reports for its Impella heart pumps. Danvers, Massachusetts-based Abiomed’s study reports relate to Impella’s premarket approvals (PMA). The company said in a news release that the FDA’s action represents “another affirmation” of the safety and effectiveness of Impella heart pumps. Impella pumps treat […]
Sinaptica’s neurostim treatment for Alzheimer’s wins FDA breakthrough nod
Sinaptica Therapeutics announced today that it received FDA breakthrough device designation for its investigational SinaptiStim AD system. Cambridge, Massachusetts-based Sinaptica designed its system to treat cognitive and functional decline in patients diagnosed with Alzheimer’s disease (AD). The system creates a novel integration of neurostimulation and brain wave monitoring technologies. It combines those with a proprietary […]
Hearing aids start selling over-the-counter in U.S.
The White House announced the rollout of over-the-counter hearing aids at major U.S. retailers today. “Starting this week, we’re making hearing aids available over the counter, so people don’t have to pay for expensive visits to specialists,” President Joe Biden said on Twitter. In August, the FDA issued a final ruling to create a new […]
FDA approves Nevro HFX iQ spinal cord stimulation
Nevro (NYSE:NVR) announced that the FDA approved its Senza HFX iQ spinal cord stimulation (SCS) system. Redwood City, California-based Nevro designed Senza HFX iQ to use artificial intelligence (AI) to learn from patients. The company says it’s the first such SCS system. It utilizes Nevro’s high-frequency 10 kHz therapy platform. The company developed it to […]
FDA sets steep increases for 2023 medical device user fees
Emergo by UL Medical device manufacturers and importers seeking to sell their products in the U.S. market can expect substantial increases in some FDA fees compared with those for 2022. The fee increases take effect at the beginning of FDA’s 2023 fiscal year, which began October 1, 2022. Notably, FDA is switching to a five-year […]
FDA clears Zeiss bipolar forceps for electrosurgery
Zeiss Medical Technology announced that it received FDA 510(k) clearance for its MTLawton disposable bipolar forceps. Jena, Germany-based Zeiss designed the forceps with a special copper-base alloy. MTLawton potentially reduces tissue adhesion and subsequent charring during the dissection of tissue. The system also features an extended shaft that helps the forceps reduce visual restrictions in […]
Phagenesis launches Phagenyx neurostim system in U.S.
Phagenesis announced it received FDA de novo clearance for its Phagenyx neurostimulation system. Manchester, England-based Phagenesis is now planning a targeted launch in the U.S. The company designed the first-of-its-kind therapy to use pharyngeal electrical stimulation (PES). It aims to restore swallowing control in patients with severe dysphagia post-stroke. The FDA granted Phagenyx breakthrough device […]
FDA clears 3D-printed titanium spacer from Life Spine
Life Spine announced today that it received FDA 510(k) clearance for its Ghost 3D-printed titanium spacer system. Huntley, Illinois-based Life Spine’s Ghost 3D-printed titanium spacer expands on the company’s interbody portfolio. These implants include options for ALIF, PLIF/TLIF and lateral procedures. The 3D-printed titanium joins PEEK and titanium in the interbody portfolio. Ghost spacers integrate […]