The FDA today temporarily loosened its enforcement on ventilators and some related devices to address manufacturing limitations and supply shortages during the coronavirus pandemic. The agency issued a temporary guidance that also covers certain anesthesia machines, respirators, oxygen conservers and delivery devices for hospital or home use. The guidance describes a limited number of modifications […]
5 companies on the front lines of the coronavirus fight
Nancy Crotti, Managing Editor and Danielle Kirsh, Senior Editor Amid the stock market roller-coaster ride that began last month, medtech companies that make devices and diagnostic tests vital to fighting COVID-19 may ultimately fare better than others, but it’s hard to tell until the virus peaks and people get back to work. At midafternoon today, […]
Lucence, Carbon Health tout COVID-19 test kits
Singapore-based Lucence said it has developed a sample collection device for viral infections such as COVID-19. Unlike other companies’ tests, Lucence’s SAFER-Sample (Stabilization of nucleic Acid Formulation for Evaluation of RNA) does not require samples from nose or throat swabs to be chilled for transport to a lab, according to the company. It comes with […]
Everlywell, Nurx to offer at-home COVID-19 tests
Home testing company Everlywell said today that it will launch a home test kit with telehealth diagnosis for COVID-19 on Monday. The Austin, Texas-based company said it will release 30,000 tests immediately and is working with multiple labs to have testing and diagnosis capacity for a quarter of a million people weekly. Consumers who have […]
CMS recommends postponing most elective procedures
The Centers for Medicare and Medicaid Services (CMS) released guidance late yesterday asking healthcare providers to postpone adult elective surgeries and procedures, including dental procedures, until further notice. The move is an attempt to preserve the supply of ventilators and personal protective equipment such as masks and gowns while protecting patients and staff from exposure […]
FDA pauses domestic inspections due to coronavirus
The FDA announced today that it has temporarily suspended all routine domestic inspections of regulated facilities during the coronavirus outbreak. The move is designed to protect agency employees as well as those who conduct inspections for the agency under contract at the state level and from a desire by regulated facilities to restrict visitors, according […]
Sterigenics asks to reopen Georgia EtO plant to fight coronavirus
Sterigenics has asked Cobb County, Ga. officials for permission to reopen its medical device sterilization plant to aid in the fight against the coronavirus. Oak Park, Ill.-based Sterigenics temporarily shut the Atlanta plant on August 26 to voluntarily upgrade emission controls for ethylene oxide (EtO), the carcinogenic gas it used to sterilize medical devices. In September, […]
Moody’s lowers outlook for U.S. medtech industry due to coronavirus
Moody’s Investors Service has lowered its outlook for the U.S. medical device industry due to lower sales it expects from the coronavirus outbreak. The Wall Street ratings service said yesterday that it has revised its EBITDA forecast for the next 12 to 18 months to 2% to 4% from 5% to 6%, but added that […]
FDA lets states approve COVID-19 tests
The FDA has issued an unprecedented new guidance that allows individual states to approve diagnostic tests for COVID-19. The guidance also describes a policy regarding the use of serological testing for antibodies to the virus without an emergency use authorization (EUA). The new guidance allows commercial manufacturers to more rapidly distribute their validated SARS-CoV-2 diagnostics […]
Quest Diagnostics, Quidel Corp. get emergency nod for COVID-19 tests
The FDA has granted two more companies’ COVID-19 tests emergency use authorizations. Tests by Quest Diagnostics (NYSE:DGX) and Quidel Corp. (NSDW:QDEL) got the nod for distribution within the U.S. without prior clearance or approval. Quest Diagnostics (Secaucus, N.J.) said it will expand testing with its new COVID-19 diagnostic this week from its high-complexity laboratories in Chantilly, Va., […]
How will coronavirus affect medtech companies that rely on elective surgeries?
One thing is likely to hurt some medtech companies more than others during the coronavirus pandemic: an elective surgical procedure slowdown. This thought had begun to emerge last week among industry watchers, but a pair of tweets over the weekend gained thousands of “likes” and retweets. The American College of Surgeons called for hospitals to […]