Fears of ventilator shortages prompts swift FDA action

On Sunday, FDA issued an immediately-in-effect policy intended to help increase availability of ventilators and their accessories as well as other respiratory devices during the COVID-19 pandemic. The guidance, issued without a public comment period, is intended to foster the continued availability of the devices while being flexible regarding manufacturer modifications made to ventilators, anesthesia gas machines, and other respiratory devices, and their accessories, in response to the COVID-19 public health emergency.

New tests, production increases, and Funding

Thermo Fischer Scientific and Abbott Laboratories joined Roche Diagnostics on a growing list of companies that have received emergency use authorizations (EUAs) from FDA for tests designed to detect coronavirus (COVID-19). BD (Becton, Dickinson and Company) is working with BioGx to request an EUA for a COVID-19 test and ramping up production of its collection devices. Meanwhile, a startup company called E25Bio managed to score $2 million in funding from Khosla Ventures to pursue its COVID-19 test.

Axonics-Medtronic battle rages on

In response to Medtronic's patent infringement claims, filed in November, Axonics Modulation Technologies is contesting the validity of each patent Medtronic has accused it of infringing. Axonics filed seven petitions with the U.S. Patent and Trademark Office (USPTO) requesting an inter partes review of each of the Medtronic patents in question. It could take up to 18 months for the USPTO to render a decision.