GE Healthcare recently announced that it received FDA premarket approval for its End-tidal (Et) Control software for general anesthesia delivery. The software is approved for use with GE Healthcare’s Aisys CS2 anesthesia delivery system. The Chicago-based company initially released the technology in Europe in 2010 and is currently used in over 100 countries. Get the […]
Bendit Technologies’ Bendit21 steerable microcatheter wins FDA clearance
Bendit Technologies today announced it received FDA 510(k) clearance for its Bendit21 microcatheter. The Israel-based company’s microcatheter is indicated for use in the treatment of the neuro, peripheral and coronary vasculature. The Bendit21 was granted clearance several months after the successful first use of the neurocatheter in the U.S. Get the full story on our […]
Archimed Group to acquire Natus Medical for $1.2B
Natus Medical today announced that it entered a definitive agreement to be acquired by Archimed for a total equity value of $1.2 billion. Through the agreement, Natus shareholders will receive $33.50 in cash for each share of Natus common stock to represent a 29% premium to the stock’s close price on April 14. “The sale […]
SonoScape secures clearance for video endoscopy system to detect gastrointestinal disease
SonoScape today announced that it received FDA 510(k) clearance for its video endoscopy system HD-550 for gastrointestinal diagnosis. The HD-550 endoscopy system has a 4-LED light source that supports high definition imaging with multi-spectrum and multi-mode. Its varying light modes enhance vascular and mucosal color contrast to reveal more details in the GI tract. Get […]
Boston Scientific wins FDA approval for imaged-guided software for DBS therapy
Boston Scientific (NYSE:BSX) today announced it received FDA approval for its Vercise Neural Navigator with StimView XT. The Marlborough, Massachusetts–based company designed its latest image-guided programming software in collaboration with Brainlab AG. It enables clinicians in real-time to visualize lead placement and stimulation modeling of the brain anatomy of patients with Parkinson’s disease or essential […]
FDA clears Transit Scientific XO Cross support catheters
Transit Scientific today announced it received FDA 510(k) clearance for its XO Cross support catheter platform for coronary use. Park City, Utah-based Transit Scientific designed the support catheter to deliver pushability, traceability and torque response for improved access in challenging peripheral lesions. It has a non-tapered, metal-alloy and polymer construction that delivers high fatigue-resistance for tough […]
FDA clears Fitbit PPG algorithm to detect AFib
Google’s Fitbit announced today that it received FDA clearance for its photoplethysmography algorithm to identify atrial fibrillation. Fitbit — which Google’s parent company Alphabet (Nasdaq: GOOGL) acquired early last year for $2.1 billion — said the PPG-based algorithm and irregular heart rhythm notification feature will be available to its U.S. consumers in the coming months. […]
FDA can’t explain record-low medical device recalls
Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according to a recent Medical Design & Outsourcing analysis of recall data. The drop was the biggest since the FDA began publicly reporting the data in 2013, and came as the regulating agency put more emphasis on fighting the COVID-19 pandemic. We reached […]
Orthofix names Kimberley Elting as orthopedics business president
Orthofix (NSDQ:OFIX) today announced it appointed Kimberley Elting to president of the global orthopedics business, effective immediately. Elting, who most recently was the company’s chief legal and development officer, will succeed Paul Gonsalves who is pursuing other opportunities. “With more than 25 years in the medical device space, a track record of success at Orthofix, […]
Staar Surgical implants first EVO Visian implantable Collamer lens
Staar Surgical today announced the first implants of the Evo Visian implantable Collamer lens in the U.S. Lake Forest, California-based Staar Surgical designed the Evo biocompatible implantable lens for the correction of myopia and myopia with astigmatism. The first implant was performed in a woman with myopia and astigmatism in her thirties who previously used […]
NanoVibronix’s UroShield receives positive guidance from UK’s NICE
NanoVibronix today received publication of guidance from National Institute for Health and Care Excellence (NICE) in the U.K. for its UroShield device. England’s Department of Health and Social Care’s NICE issued guidance suggesting that UroShield has the potential to provide significant patient and healthcare system benefits to prevent catheter-associated urinary tract infections. Further U.K.-based research […]