The FDA’s draft guidance for the form and content of unique device identifiers (UDIs) may have lacked the controversy of some other policies, but the 2016 draft languished for five years even though only 10 comments appear in the docket. While the agency made some concessions regarding substantial edits of the draft, the final retains a need for data delimiters in the definition of “easily readable” plain text in UDIs, despite industry’s argument that this was not required in the agency’s UDI rulemaking.
The FDA granted breakthrough device designation for the Hyalex Cartilage System, a biomimetic materials platform designed to restore function and repair cartilage defects in the knee. The system, developed by Hyalex Orthopaedics Inc., combines two polymers that improve adhesion on one side and create a low-friction surface that protects the cartilage counterface on the other.
A large health system in Minnesota recently became the first in the world to have completed a structural heart procedure, or any other surgical procedure for that matter, using any kind of 4D hologram technology. The technology was developed by venture capital-backed startup Echopixel Inc., and it is intended to improve both surgical precision and outcomes in minimally invasive procedures.
While U.S. lawmakers continue their debate on reducing spending for prescription drugs, government payers are exploring innovative reimbursement ideas to cover gene and cell therapies that could cost millions of dollars for a cure or a durable effect against rare diseases.
The U.S. Securities and Exchange Commission (SEC) has had Parallax Health Sciences Inc. in its crosshairs at least as far back as April 2020, when the agency suspended trading of the company’s shares. In the latest development, the SEC charged the company and two of its executives with misleading investors regarding the availability of COVID-19 screening tests and personal protective equipment, actions the agency said were undertaken to exploit the pandemic in an effort to boost the company’s share prices.
Hyerfine Inc. and Liminal Sciences Inc. have joined a growing field of med-tech startups that are combining with blank check companies as an alternative path for venture-backed companies to an initial public offering (IPO). On Thursday, the companies announced a three-way combination with Healthcor Catalio Acquisition Corp., a special purpose acquisition company (SPAC), in a deal valued at approximately $580 million.
With 15 more U.S. states signing on, a bankruptcy settlement appears to be in sight for privately owned Purdue Pharma LP. It also has U.S. lawmakers calling for reforms to the country’s bankruptcy laws.
U.S. Rep. Carolyn Maloney (D-N.Y.) came out swinging against the biopharma industry’s innovation talking point July 8 when she released a House Oversight Committee staff report on U.S. drug prices and the games drug manufacturers play to delay competition.
The FDA’s attempts to thwart the use of electrostimulation devices for self-injurious and aggressive behavior came up short in an appeals court hearing of Rotenberg v. FDA, largely because the FDA’s approach suggested the agency would control the practice of medicine.
The whopper June buyout of by Morphosys AG of Constellation Pharmaceuticals Inc. brought renewed attention to myelofibrosis (MF) and other players in the space, such as Sierra Oncology Inc.
RSS
