From Accenture’s AI-powered app to help the visually impaired to Rayovac getting clearance from Health Canada, here are seven medtech stories we missed this week but still thought were worth mentioning. 1. Accenture touts AI-powered app for visually impaired Accenture announced in a July 28 press release that it has developed an artificial intelligence–powered way to […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Quantitative Insights wins FDA de novo nod for QuantX machine learning cancer diag
Quantitative Insights said yesterday it won FDA de novo clearance for its QuantX Advanced computer-aided diagnosis platform designed for evaluating breast abnormalities, touting it as the 1st such program to integrate machine learning. The Chicago-based company said the software platform includes embedded tools, including its QI Score and Similar Case Database Compare, which provide similarity […]
FDA unveils Digital Health Pre-Certification Program
The FDA today revealed its Digital Health Innovation Action plan, including a new software Pre-certification Program through which the FDA would shift its regulatory focus from the product to the developers for digital health companies. The federal watchdog said that the program looks to shift its oversight of digital health software and tech as software […]
FDA grants priority review to Kaleo’s auto-injector for infants, kids
Kaleo said today that the FDA granted priority review to a supplemental new drug application for Kaleo’s Auvi-Q 0.1 milligram epinephrine auto-injector. The privately-held pharmaceutical company touted this version of its device as the first specifically designed for the treatment of life-threatening allergic reactions in infants and small kids. The 0.1 mg auto-injector sports a shorter […]
UPDATE: Aspect Imaging wins FDA 510(k) for Embrace neonatal MRI
Updated to include comment from Aspect Imaging The FDA today granted 510(k) clearance to Aspect Imaging‘s Embrace Neonatal magnetic resonance imaging device, which it touted as the 1st MRI device specifically designed for neonatal brain and head imaging. The Embrace Neonatal MRI system is designed specifically for imaging neonatal heads, and can be used on […]
Spectranetics wins FDA nod for Stellarex DCB
Spectranetics (NSDQ:SPNC) said today that its Stellarex drug-coated balloon won FDA pre-market approval. The device is designed to treat patients with peripheral arterial disease, bringing blood flow back to the superficial femoral and popliteal arteries. Get the full story at our sister site, Drug Delivery Business News.
Medtronic wins Health Canada approval for MRI-safe line of CRT-Ds
Medtronic (NYSE:MDT) said today its Medtronic Canada subsidiary received Health Canada approval for its line of MRI-conditional cardiac resynchronization therapy defibrillators, touting them as the 1st MRI CRT-Ds cleared in the region. With the new clearance, Fridley, Minn.-based Medtronic’s Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems, which are currently available in the […]
Surmodics to launch pivotal trial for drug-coated balloon
Surmodics (NSDQ:SRDX) said today that it won investigational device exemption from the FDA to launch a pivotal trial of its SurVeil drug-coated balloon. The trial is slated to compare the Eden Prairie, Minn.-based company’s device with Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon for patients with peripheral artery disease in the upper leg. Get the full story at our […]
Vertera Spine wins 510(k) for Coalesce interbody fusion device
Vertera Spine said today it won FDA 510(k) clearance for its Coalesce lumbar interbody fusion device for use in anterior, transforaminal, posterior and lateral lumbar interbody fusion procedures. The Atlanta-based company said its newly cleared Coalesce fusion device features the company’s proprietary porous PEEK biomaterial. Vertera spine said it will be launching the Coalesce for TLIF […]
India approves Anika’s Monovisc osteoarthritis treatment
Anika Therapeutics (NSDQ:ANIK) said today that regulatory authorities in India approved its single injection viscosupplement, Monovisc, as a therapy for pain associated with osteoarthritis in synovial joints. The Bedford, Mass.-based company’s product is already available in the U.S. Canada and Europe. Anika said it hopes to expand into Australia, New Zealand and other international markets in the […]
FDA clears Invacare’s Elyria, Ohio wheelchair manufacturing facility
Invacare (NYSE:IVC) said today that it received notice from the FDA that it can resume wheelchair production operations at its Elyria, Ohio-based manufacturing facility. The company said that the letter followed the completion of multiple procedural milestones, including an on-site inspection of the facilities by the FDA on May 30. “Since I arrived at Invacare in 2015, […]