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 […]
Food & Drug Administration (FDA)
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.
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 […]
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, […]
Arch Therapeutics submits FDA 510(k) for AC5 wound treatment gel
Arch Therapeutics (OTC:ARTH) said today it submitted a 510(k) application to the FDA as it seeks approval for tis AC5 topical gel designed for hemostatic and wound care, seeking an indication for external wounds. The Framingham, Mass.-based company said that it will still seek regulatory approval for its other AC5 products, designed for internal use, through […]
Samumed wins orphan drug status for inhaled IPF therapy
Samumed said today that the FDA awarded orphan drug status to its inhaled idiopathic pulmonary fibrosis therapy, SMo4646. The IPF therapy is administered using a nebulizer and can be used as a montherapy or in combination with pirfenidone or nintedanib, according to the San Diego-based company. Get the full story at our sister site, Drug Delivery […]
Healthcare fund Gurnet Point buys Innocoll’s bioresorbable collagen matrix
Healthcare investment fund Gurnet Point said today that it completed its acquisition of pharmaceutical and medical device company Innocoll. According to the deal, Gurnet Point is slated to buy Innocoll for 1.75 per share in cash and up to $4.90 in cash from a contingent value right, in a deal valued up to $209 million. Get the full […]