Conformis (NSDQ:CFMS) announced today that it received more than $4.7 million through the U.S. Small Business Administration’s Paycheck Protection Program. The Billerica, Mass.-based joint replacement implants company entered into the promissory note totaling $4,719,800 with East West Bank in an effort to mitigate the negative impacts of the COVID-19 pandemic. The Coronavirus Aid, Relief & Economic […]
coronavirus
Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.
Are coronavirus antibody tests all they’re cracked up to be?
With pressure mounting to get Americans back to work, the new focus is on tests that purport to indicate antibodies to the SARS-CoV-2. These serological tests are supposed measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection, like COVID-19. Many companies in China have […]
How Vecna Robotics is helping to combat ventilator shortages
Vecna Robotics is part of the growing number of companies combating the shortage of ventilators caused by the COVID-19 crisis. Waltham, Mass.-based Vecna Robotics, along with sister companies VecnaCares and Vecna Healthcare, partnered with MIT CSAIL, the Toyota Research Institute and others to develop an automated manual resuscitator called Ventiv. Ventiv can be used in conjunction with […]
FDA: Coronavirus may extend medtech application reviews
The FDA may not be able to meet its deadlines for reviewing medical device applications due to constraints posed by the coronavirus pandemic, Commissioner Stephen Hahn announced yesterday. The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) are still on track to meet the goals set in […]
BREAKING: EU-MDR is postponed by 1 year due to coronavirus pandemic
The European Parliament voted today to postpone implementation of its new Medical Device Regulation (MDR) by one year, giving medtech companies a welcome reprieve from their scramble to comply. EU MDR, originally scheduled to go into effect May 26, 2020, will now take effect May 26, 2021, if individual member states approve. Get the full […]
3M donates $20m toward coronavirus pandemic fight
3M (NYSE:MMM) will donate $20 million to groups supporting frontline healthcare workers, vulnerable populations disproportionately affected by the virus and medical research initiatives. “Since the outbreak began, 3M has addressed the COVID-19 pandemic from all angles and across all stakeholders, and this includes supporting our community partners around the world,” CEO Mike Roman said in a […]
FDA approves Q-tip-like swabs to allow patient self-testing for COVID-19
The FDA announced today that spun synthetic swabs — with a design similar to Q-tips — could be used to collect samples from patients suspected of having COVID-19. Patients could even take the samples themselves from the front of the nose, the agency said. The solution could help solve multiple problems: The nationwide shortage of […]
HHS to pay $336m to GE, Ford for ventilators
The U.S. Dept. of Health and Human Services (HHS) announced today that it awarded a new $336 million contract to General Electric (NYSE:GE), in partnership with Ford, for ventilator production under the Defense Production Act. Under the contract, GE and Ford are slated to produce 50,000 ventilators by July 13, following President Donald Trump’s April 2 […]
Soligenix soars on COVID-19 vaccine licensing agreement with Boston Scientific
Soligenix (NSDQ:SNGX) skyrocketed up 89% in premarket trading this morning after announcing today that it entered into an exclusive worldwide licensing agreement with Boston Scientific (NYSE:BSX) for its CoVaccine HT novel vaccine adjuvant for COVID-19. Shares of SNGX were up 12.5% at $1.58 per share in mid-morning trading today as well. Boston Scientific’s BTG Specialty Pharmaceuticals […]
Theranos founder Elizabeth Holmes’ trial date pushed back amid coronavirus
Ex-Theranos CEO Elizabeth Holmes will see her federal court trial over fraud charges start on Oct. 27, instead of July 28, amid coronavirus pandemic worries — as well as prosecutors’ desire to add more charges against her. “We’re in unchartered waters and unchartered territories,” U.S. District Judge Edward Davila said yesterday during a trial status […]
Stryker gains emergency nod for respirator decontamination
The FDA has granted Stryker (NYSE:SYK) an emergency use authorization to decontaminate used N95 respirators using the company’s Sterizone VP4 sterilizer during the coronavirus outbreak. The Sterizone VP4 uses vaporized hydrogen peroxide to sterilize up to 20 of the masks in one cycle, according to the FDA. Stryker’s sterilizer is the fourth that uses vaporized hydrogen […]