CoNextions announced that it won FDA 510(k) clearance for its Coronet system for the fixation of tissue to bone and tissue to tissue. The Coronet system is a tenodesis product designed to improve the soft tissue fixation strength of these types of repairs when compared to conventional suture repairs. Salt Lake City–based CoNextions developed the […]
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Johnson & Johnson: Clinical study of potential coronavirus vaccine could start by end of year
Johnson & Johnson (NYSE:JNJ) said today that its Janssen Pharmaceutical Cos. has forged a partnership with the Beth Israel Deaconess Medical Center (BIDMC) to support coronavirus vaccine development. Janssen and the virology lab led by Dr. Dan Barouch at BIDMC have started preclinical testing of multiple vaccine prospects, with the goal of identifying a COVID-19 […]
Myomo drops on Q4 losses
Myomo (NYSE:MYO) shares took a hit today on fourth-quarter results that missed the consensus forecast for earnings but topped the revenue projections. The Cambridge, Mass.-based commercial-stage medical robotics company yesterday evening posted losses of $2.8 million, or -$4.81 per share, on sales of $1.5 million for the three months ended Dec. 31, 2019, for a 2.6% […]
Roche secures emergency use authorization for coronavirus test
Roche (SWX: RO, ROG) announced today that its Cobas SARS-CoV-2 test is the first commercially distributed diagnostic test to receive an FDA emergency use authorization during the coronavirus pandemic. The tests are also now available in countries accepting the EU’s CE Mark. FDA didn’t object to Roche pre-positioning its test, so labs are now able to initiate testing […]
Trump orders more general use respirators for healthcare workers
Amid the COVID-19 pandemic sweeping the globe, President Donald Trump issued an executive order to increase the availability of personal respiratory devices for healthcare workers. In a memorandum released by the White House on March 10, Trump declared that public health experts anticipate shortages in the supply of respirators available for use by healthcare workers […]
Eyebrain Medical raises $23.8m
Eyebrain Medical yesterday filed an amendment to its SEC Form D to confirm the sale of more than $23.8 million in an equity offering. The offering is slated to collect just shy of $24 million, leaving the Costa Mesa, Calif.-based company with $180,026 remaining to be sold. Eyebrain Medical made the first sale on July […]
Ocular Therapeutix dips on big losses, missed projections
Ocular Therapeutix (NSDQ:OCUL) shares were marginally down today on fourth-quarter results that came up short the consensus forecast after massive losses. The Bedford, Mass.-based ophthalmic insert maker posted losses of $26 million, or -53¢ per share, on sales of $2.3 million for the three months ended Dec. 31, 2019, for a 49.5% bottom-line slide despite nearly […]
Ra Medical Systems appoints new CEO
Ra Medical Systems (NYSE:RMED) this week said it appointed Will McGuire as CEO, effective March 30. Andrew Jackson has served as interim CEO since August and will remain as the company’s chief financial officer. “Will’s extensive industry experience, particularly in the vascular space, makes him an ideal fit to lead Ra Medical,” chairman Martin Colombatto said […]
U.K. court bars Edwards TMVR sales, gives Abbott win in patent spat
A judge in the England issued an injunction yesterday barring Edwards Lifesciences from selling its Pascal transcatheter mitral valve repair (TMVR) device in the U.K. A different judge had previously denied Abbott’s petition for such an injunction. Yesterday, Judge Colin Birss of the High Court of England and Wales also ruled that two patents held […]
J&J’s Janssen, Thermo Fisher Scientific to collaborate on oncology diagnostic
Thermo Fisher Scientific (NYSE:TMO) announced today that it entered into an agreement with Johnson & Johnson‘s (NYSE:JNJ) Janssen Biotech to co-develop a companion diagnostic (CDx) in oncology. Under the agreement, Thermo Fisher is set to collaborate with Janssen’s R&D scientists to validate biomarkers for use with Thermo Fisher’s Oncomine DX target test in identifying variant-positive patients for […]
Hologic announces 1000th Panther molecular diagnostics system placement in U.S.
Hologic (NSDQ:HOLX) announced today that it completed the placement the 1000th Panther automated molecular instrument system in a U.S. diagnostics laboratory. The Panther system was unveiled at PathGroup in Nashville, Tenn. PathGroup is a large provider of anatomic, clinical and molecular pathology laboratory services with over 15,000 physician clients, hospitals and surgery centers across the country. […]