Medtronic (NYSE: MDT) today announced that it received CE mark approval for its SenSight directional lead system for deep brain stimulation therapy. SenSight works seamlessly with certain Medtronic neurostimulators including the Percept PC neurostimulator. It enhances the detection of local field potentials and has directional stimulation for individualized and patient-specific data with additional programming features to […]
4Web Medical wins FDA clearance for lumbar plating system
4Web Medical this week announced that it received FDA 510(k) clearance for its lumbar plating solution. The plating system have a variety of modular plating configurations to address multiple lumbar spine pathologies and approaches. “Our continued commitment to new product development led to revenue growth in FY 2020 driven by the launch of the Stand […]
Koru Medical names Linda Tharby as CEO
Koru Medical Systems (NSDQ:KRMD) today announced that it has appointed Linda Tharby as president and CEO, effective April 12. Tharby will succeed interim CEO Jim Beck, who will continue to serve on the company’s board of directors. “On behalf of the board of directors and our entire company, I’d like to thank Jim for stepping up […]
Zimmer Biomet names chief operating officer
Zimmer Biomet (NYSE:ZBH) today said it has appointed Ivan Tornos to the newly-created role of chief operating officer. Tornos previously served as group president of orthopedics and was later appointed group president of global businesses and the Americas. As chief operating officer, Tornos will be responsible for overseeing all global businesses at Zimmer Biomet, as well […]
FDA clears Catalyst OrthoScience reverse shoulder system
Catalyst OrthoScience today announced that it received FDA 510(k) clearance for its reverse shoulder system. The reverse shoulder system is a total shoulder prosthesis designed for severe shoulder arthritis patients in conjunction with a grossly deficient or non-functional rotator cuff. The design is inverted compared to traditional anatomic total shoulder prosthesis where the articulating sphere […]
Izi Medical Products launches fully automatic biopsy system
Izi Medical Products today launched its Quick-Core Auto Biopsy System for soft tissue biopsies. Quick-Core Auto is a lightweight, fully automatic biopsy device that builds upon the company’s previous semi-automatic biopsy system. “Izi has made significant strategic investments to enhance its Quick-Core tissue biopsy portfolio, including expanding the length and gauge size of its semi-automatic […]
Roche launches SARS-CoV-2 variant test for research use
Roche (SWX: RO, ROG) today announced that it has launched its Cobas SARS-CoV-2 Variant Set 1 test to detect mutations in the COVID-19 virus. The test is designed to differentiate mutations found in variants that originated in the U.K. (B.1.1.7), South Africa (B.1.351) and Brazil (P.1). It runs on its high-volume Cobas 6800/8800 systems and is a research […]
5 at-home COVID-19 diagnostic tests you should know
The wait for a completely at-home COVID-19 test ended in November when the FDA authorized the first ones that enabled people to obtain samples and results at home. The agency since then has authorized five at-home COVID-19 tests for emergency use since the beginning of the pandemic. The kits are made to take a sample […]
Fujifilm wins CE mark for rapid COVID-19 antigen test
Fujifilm (TSE:4901) today announced that it received CE mark approval for its antigen test kit to detect COVID-19. The rapid diagnostic test detects SARS-CoV-2 infection. It uses the company’s silver application immunochromatography method that is based on silver amplification technology used in the photo developing process. Fujifilm said that the antigen test is highly sensitive with […]
Qardio lands 510(k) for ambulatory ECG device
Qardio this week announced that it received FDA 510(k) clearance for its QardioCore ambulatory ECG device. QardioCore is an extension of Qardio’s remote patient monitoring platform for primary care and hypertension monitoring to acute care and cardiology. The device requires no special skin preparation, gels, adhesives or patches. It can be easily self-fit, removed and […]
Avinger slides on mixed bag Q4 results
Avinger (NSDQ:AVGR) posted fourth-quarter results today that missed the earnings consensus on Wall Street but matched on sales. The Redwood City, Calif.-based company — maker of an image-guided, catheter-based peripheral artery disease treatment — reported losses of –$4.6 million, or –7¢ per share, on sales of $2.73 million for the three months ended Dec. 31, 2020, […]