Ex-Theranos CEO Elizabeth Holmes’ federal fraud trial will now start in March 2021 amid delays related to the COVID-19 pandemic. Judge Edward Davila decided yesterday that jury selection will start on March 9, with opening arguments taking place around March 16 in U.S. District Court in San Jose, Calif. It is possible that some or […]
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Theranos founder Elizabeth Holmes is questioning grand jury selection process
Prosecutors are asking a federal judge to mostly deny ex-Theranos CEO Elizabeth Holmes’ request to inspect grand jury selection records. Holmes, according to the prosecutors’ July 31 response to Holmes’ July 30 motion, is adopting a strategy of other defendants indicted during the COVID-19 pandemic — to suggest without basis that was the grand jury […]
Siemens Healthineers to buy Varian for $16.4b
Siemens Healthineers (ETR: SHL) will acquire Varian Medical Systems (NYSE:VAR) in a $16.4 billion deal to create what the companies say will be the most comprehensive cancer care portfolio in the industry. SHL shares closed down –8.95% to €40.02 apiece in trading in Germany today, while VAR shares are up 21.61% to $173.57 apiece as of midday NYSE […]
Hologic blasts American Cancer Society over new Pap test guidelines
Hologic (NSDQ:HOLX) — a major company in the Pap and human papillomavirus (HPV) testing space — is criticizing the American Cancer Society over new cervical cancer screening recommendations that prefer simply doing HPV tests every five years. “Although all the screening tests are good at finding cancer and pre-cancer, primary HPV testing is better at finding […]
Smith+Nephew misses expectations in Q2
Smith+Nephew (LON:SN) today reported Q2 results that missed the consensus forecast of analysts as the COVID-19 pandemic drove revenue down nearly 30%, to $901 million. The British orthopedics, sports medicine and wound care products company, however, also reported that it saw elective procedures resume across the U.S. and much of Europe by the time the quarter […]
Aetna accuses Conformis of trying to use patient’s lawsuit to compel coverage
Joint replacement implant maker Conformis (NSDQ:CFMS) is improperly using a Colorado man’s denial of benefits lawsuit to force Aetna to cover its customized knee implants, the health insurer recently argued in a federal court filing. Billerica, Mass.-based Conformis joined John Michael Schaub of Golden, Colo., in his lawsuit against Aetna, filed in May in U.S. District Court […]
FDA clears Ambu single-use duodenoscope
Ambu announced today that FDA has cleared its aScope Duodeno — a sterile, single-use duodenoscope meant to avoid the deadly superbug outbreaks that cropped up around reusable versions of the scopes. Other companies — including Boston Scientific (NYSE:BSX), Hoya’s (TYO:7741) Pentax subsidiary, and Olympus (TYO:7733) — have been releasing either fully disposable duodenoscopes or duodenoscopes with disporable endcaps […]
Sirius Medical raises nearly $5m to commercialize non-radioactive tumor localization system
Sirius Medical has raised €4.4 million ($4.9 million) as it seeks to commercialize its Sirius Pintuition non-radioactive tumor localization system. News of the money raise comes about a month after the Eindhoven, the Netherlands-based Sirius announced that it had won a CE Mark for the system. FDA clearance is pending. The Series A round was […]
Smith+Nephew launches next-gen surgical robotics system
Competition continues to heat up in the robotic orthopedic surgery space, with Smith+Nephew (LON:SN) today announcing the launch of its next-gen Cori surgical system. Cleared by FDA and available for both total and unicompartmental knee arthroplasty, the handheld Cori robotics platform is meant to be faster than S+N’s previous Navio system. On top of Cori, […]
NovaSight raises $8m for lazy eye treatment device
Israeli startup NovaSight announced today that it has raised $8 million in a Series A round meant to support a large multi-center randomized pivotal study of its lazy eye treatment device. Study results will support potential FDA 510(k) clearance for the device. The money will also support development of future eye care products such as […]
FDA plans to resume onsite inspections later this month
FDA has a goal of restarting on-site inspections during the week of July 20 — four months after it temporarily halted them — though there will be changes due to the COVID-19 pandemic. The agency today said that it will pre-announce inspections to FDA-regulated businesses. Said FDA: “This will help assure the safety of the […]
