Orthopedics device startup Amber Implants BV has received an FDA breakthrough designation for its cementless spinal implant Vcfix. The system is designed to treat vertebral compression fractures (VCFs), which can cause patients severe back pain and limited mobility. Currently, VCFs are treated with injection of bone cement into the vertebra.

Advocates have continued to press for more widespread use of rapid antigen tests in the home as a primary instrument for returning to economic normalcy, and the FDA has granted an emergency use authorization (EUA) to Acon Laboratories Inc., of San Diego, for the company’s Flowflex rapid antigen test for at-home use. According to the FDA, Acon said the COVID-19 test will be produced at a rate of 200 million a month by February 2022, a clip that should go a long way toward restoring vigor to a lagging U.S. economy.

The FDA’s final rule for the de novo petition process took nearly three years to wrap up, a timeline likely extended by the COVID-19 pandemic, but the final rule retains some controversial features seen in the 2018 draft. Among these is a provision for FDA inspections before determining whether to grant the petition, a provision that was blasted by multiple commenters as extra-statutory and a needless source of drag on these applications.

The FDA has granted clearance of Siemens Medical Solutions Inc.’s photon-counting computed tomography (CT) scanner, Naeotom Alpha. The new diagnostic imaging device uses a photon-counting detector that measures individual X-rays that pass through a patient's body, as opposed to current systems that use detectors that measure the total energy contained in X-rays at once. The scanner then transforms the information from the X-ray photons into a detailed three-dimensional image, which can be used by physicians to assist diagnosis or treatment preparation planning.

Jury trials for product liability litigation are not always the last stop for these lawsuits, but courts are more frequently banning device makers from presenting evidence related to premarket filings in these proceedings. One example of this was the pelvic mesh trial of McGinnis v. Bard, in which the trial judge allowed the plaintiff to make nearly two dozen references to the FDA without allowing rebuttal from counsel for the defense, thus biasing a jury that awarded the plaintiff $68 million without hearing the entirety of the evidence.

The FDA unveiled a draft guidance addressing the responsibilities of clinical investigators for safety reporting for investigational drugs and devices, a novel attempt to combine the disparate adverse event reporting timelines for investigational drugs and devices.

Once upon a time, Intarcia Therapeutics Inc. was a biotech unicorn valued at $3.5 billion. Its allure was its implantable Medici drug delivery system that consisted of a mini pump about the size of a matchstick. But a unicorn’s life is never completely charmed. Intarcia faced obstacles along the way – two complete response letters from the U.S. FDA and the denials of three formal dispute resolution requests. Now it looks like this story won’t have a happy ending.

Nonagen Bioscience Corp. received FDA breakthrough device designation for its liquid biopsy assay designed to predict response to treatment for bladder cancer. The test, Oncuria, measures 10 protein biomarkers in a urine sample and uses an algorithm to predict whether patients will respond to Bacillus Calmette-Guerin (BCG), the first-line treatment for bladder cancer, or should proceed to another treatment option.

The FDA’s device center has been nudging electronic device submissions along for several years and has now posted a draft guidance related to the contents of those submissions. The agency said it will notify industry by Sept. 30, 2022, of the date upon which electronic submissions will be compulsory, although it will offer a one-year grace period for companies that have not yet gone fully electronic with their premarket submissions.

Selux Diagnostics Inc. has received breakthrough device designation from the FDA for its Next Generation Phenotyping (NGP) platform for positive blood culture and sterile body fluid samples. The NGP technology is a diagnostic platform designed to help with the delivery of personalized antimicrobial therapies within 24 hours. The Boston-based company is hoping the technology can tackle the global antibiotic resistance crisis. According to the World Health Organization, antimicrobial resistance is one of the top 10 global public health threats facing humanity.