CoreLink announced today that it received FDA 510(k) clearance for its F3D-C2 standalone cervical system for ACDF procedures. The F3D-C2 standalone cervical device eliminates the need for a supplemental fixation plate to make ACDF (anterior cervical discectomy and fusion) procedures easier to complete and a faster process overall. St. Louis-based CoreLink’s system includes its 3D-printed […]
FDA
Masimo announces drug-free opioid-withdrawal device
Masimo (NSDQ:MASI) announced that it received FDA de novo classification for its Bridge neuromodulation-based opioid withdrawal device. Bridge uses neuromodulation to aid in reducing the symptoms associated with opioid withdrawal. Irvine, Calif.-based Masimo touts it as the first evidence-based, drug-free, non-surgical device of its kind. The wearable, single-patient-use, percutaneous neurostimulator fits behind the ear and applies […]
FDA clears Orthofix Firebird SI fusion system
Orthofix (NSDQ:OFIX) announced today that it received FDA 501(k) clearance for its Firebird SI 3D-printed titanium bone screw. Lewisville, Texas-based Orthofix touts its Firebird SI as the first 3D-printed titanium bone screw to launch in the U.S. for treating sacroiliac (SI) joint dysfunction. The fusion system is designed to both compress and stabilize the SI joint, […]
Beckman Coulter COVID-19 antibody test receives FDA EUA
Beckman Coulter announced today that it received FDA emergency use authorization (EUA) for its Access SARS-CoV-2 IgG assay. Brea, Calif.-based Beckman Coulter has already shipped its COVID-19 antibody assay to more than 400 hospitals, clinics and diagnostics laboratories in the U.S. and began distribution globally to countries that accept EUA and its recently garnered CE […]
MedTech 100 roundup: Markets dip again
Medtech stocks continue to fluctuate amid the COVID-19 pandemic, with a significant dip in the shares belonging to the industry’s biggest names. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 81.88 points at the end of last week (June 26). That total represents a -3.7% decrease […]
Partnership will study use of existing drugs for COVID-19 and and more
A new collaboration funded by in part by $1.1 million from the FDA is working on finding new uses for existing drugs for areas of high unmet medical need — with a pilot project focused on treatments for COVID-19. The Critical Path Institute (C-Path) this week announced the launch of the CURE Drug Repurposing Collaboratory […]
FDA clears Masimo respiration sensor
Masimo (NSDQ:MASI) announced today that its Centroid wireless orientation, activity and respiration rate sensor received FDA clearance. Centroid is a wearable sensor designed to monitor patient position in an effort to avoid preventable pressure ulcers, while also alerting clinicians to sudden movements, such as fall-like events. The device also detects chest movements to continuously provide respiration […]
FDA OKs Circadia’s radar-powered tool in battle against COVID-19
Healthcare staff monitoring COVID-19 patients for respiratory distress will have a new radar-powered tool at their disposal thanks to an expedited FDA clearance for Circadia Health. London-based Circadia Health announced today the agency gave a green light to its Contactless Respiration Rate (CResp) monitoring systems and c100 device. “Our C100 uses radar to wirelessly look […]
FDA approves Medtronic’s latest DBS
Medtronic (NYSE:MDT) said today that it has received FDA approval for the Percept PC deep brain stimulation (DBS) system. The medical device giant is touting Percept PC’s BrainSense technology, which is designed to sense and record brain signals while delivering DBS therapy to people with neurological disorders such as Parkinson’s disease. BrainSense enables more personalized, […]
FDA approves Mainstay Medical neurostim device
Mainstay Medical announced that it received FDA premarket approval for its ReActiv8 implantable neurostimulation system for chronic low back pain. ReActiv8 treats intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy and are not candidates for spine surgery, according to a […]
Hahn says FDA will keep some COVID-19-era changes in place
The head of the FDA says some changes the agency made during the height of the COVID-19 pandemic will become permanent. Dr. Stephen Hahn told members of the Medical Device Innovation Consortium (MDIC) on June 19 that the agency will rely even more on real-world evidence regarding the performance of approved or cleared devices and […]