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 […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
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, […]
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 […]
New GSK chief executive to refocus pipeline
GlaxoSmithKline‘s (NYSE:GSK) new chief executive, Emma Walmsley, signaled in April that she plans to cut programs in the company’s pharmaceutical pipeline that aren’t generating enough value, including older antibiotics. “We’ll need to be switching off some areas,” Walmsley said, according to Reuters. She is slated to detail her plans this week when she presents second quarter […]
AdvaMed protests FDA update to “intended use” language
AdvaMed last month sent a letter to the FDA criticizing a new rule which changes the group’s definition of “intended uses”, saying it could negatively impact scientific communication, device development and make manufacturer’s liable for any off-label use by merely knowing it exists. The letter was released last week by the FDA, and is in […]
FDA clears updated labeling, design for FujiFilm ED-530XT duodenoscopes
Fujifilm Medical (TSE:4901) today issued a select voluntary recall for its model ED-530XT duodenoscopes after the FDA cleared an update to the design and labeling of the device, intending to supply customers with new forceps elevator mechanism from Platform Lift, O-ring seals, distal end caps and updated operations manuals. The company said it won FDA clearance […]
DarioHealth wins FDA nod for Android diabetes app
DarioHealth (OTCQB:DRIO) said yesterday it won FDA 510(k) approval for its Dario diabetes management application on certain Google (NSDQ:GOOG) Android devices. The approval expands the Israel-based company’s availability from exclusively Apple (NSDQ:AAPL) iOS products, which it has had clearance on since winning FDA clearance for its Dario blood glucose monitoring system in December 2015. DarioHealth said the […]
Trump pushes ‘America First’ policy with pharmaceutical packaging industry
Donald Trump yesterday revealed an initiative to bring jobs and investment into the U.S. drug packaging industry, spearheaded by Corning Inc. (NYSE:GLW), Merck (NYSE:MRK) and Pfizer (NYSE:PFE). At the ‘Made In America’ event, Trump announced that the companies are making a $500 million investment to create 1,000 jobs at manufacturing facilities in New York, New Jersey and an unnamed site in […]