Devices
Aspen Tech Policy Hub fellow Daniel Bardenstein says FDA should require all medical device makers to include a baseline of certain cybersecurity protections in their products and to build in a feature that allows safe vulnerability scanning of their devices without disrupting their safe operation with patients. In an interview
Devices
FDA has cleared a Casio America 510(k) for the DZ-D100 DermoCamera and the DZ-S50 scope for skin observation by dermatologists. The devices were developed in collaboration with dermatology professionals and deliver both standard sized and close-up shots of an affected area with a single unit, according
FDA Policy/General
Federal Register notice: FDA has announced a 3/15 virtual meeting entitled “FDA Hiring and Retention Final Assessment” and an opportunity for public comments. The meeting is intended to discuss an independent assessment performed by Booz Allen Hamilton. Comments can be submitted until 5/16. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is debarring Brian Michael Parks for five years from importing or offering for import any article of food (including dietary supplements) or drug into the U.S. Parks was earlier convicted of one felony count for distributing an unapproved new drug with the intent to defraud
Drugs
FDA has cited Denali Therapeutics’ preclinical toxicology assessment and has requested changes to the company’s clinical trial protocol, informed consent form, and investigator brochure, according to the company’s account of a formal clinical hold notification from the agency on its DNL919 IND, an Alzheimer’s candidate. Last month,
Drugs
FDA has accepted for review a Spectrum Pharmaceuticals NDA for poziotinib and its use in treating patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The user fee review action target date is 11/24. The company is seeking
Drugs
CDER’s Office of Generic Drugs says it reached a milestone last year when it approved 100-designated “Competitive Generic Therapy (CGT)” ANDAs. The CGT pathway for generic drugs helps incentivize the entry of drugs with “inadequate generic competition” to the market. “This milestone is a sign the program is
Drugs
ProQR Therapeutics says a pivotal Phase 2-3 trial (Illuminate) evaluating sepofarsen for treating genetic eye disease CEP290-mediated Leber congenital amaurosis 10 (LCA10) did not meet its primary endpoint or notable secondary endpoints. The company said there was no benefit observed in either treatment arm versus sham against the
Devices
FDA has cleared a Motus GI Holdings 510(k) for the Pure-Vu EVS System for colonoscopies. The device is intended to improve speed of set-up, enhance navigation capabilities in tortuous anatomy, improve cleansing capabilities and enable physicians to overcome the challenges of poorly prepared colons during a colonoscopy,
Devices
FDA has granted Datar Cancer Genetics a breakthrough device designation for its TriNetra-Prostate blood test to detect early-stage prostate cancer. The designation is based on studies showing that the test can detect early-stage cancer with high accuracy (greater than 99%) without any false positives, according to the
FDA Policy/General
Spore Test Strip Put Into Class 2 2/11/2022 Federal Register notice: FDA is classifying the spore test strip into medical device Class 2 (special controls). The action was taken in response to a Steris de novo classification request for its Verify Spore Test Strip for S40. It consists
FDA Policy/General
Boston Scientific has acquired the gynecology and urology portfolio of Distal Access, a Salt Lake City-based company that designs minimally invasive medical devices. The portfolio includes the Resectr Tissue Resection Device, a single-use device for removing uterine polyps. Isto Technologies, an orthobiologics company working to develop ways to
FDA Policy/General
DEVICES FDA has cleared a Spinal Resources 510(k) for its Swedge Pedicle Screw System. The device offers cobalt-chromium and titanium tulips, double lead and cortical cancellous threads; polyaxial, monoaxial, reduction and iliac screws, and minimally invasive spinal surgery options, according to the company. Currently, it is cleared for
FDA Policy/General
Federal Register notice: FDA is classifying the spore test strip into medical device Class 2 (special controls). The action was taken in response to a Steris de novo classification request for its Verify Spore Test Strip for S40. It consists of a carrier or strip with a known number of
FDA Policy/General
Federal Register notice: FDA has classified the adjunctive predictive cardiovascular indicator into medical device Class 2 (special controls). The action is in response to an Edwards Lifesciences de novo classification request for its Acumen Hypotension Prediction Index Feature Software. The agency has identified it as being a prescription device that
Devices
FDA has approved Senseonics Holdings’ next-generation Eversense E3 continuous glucose monitoring (CGM) system and its use for up to six months in diabetic patients aged 18 years and older. The device is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements
Biologics
Y-mAbs Therapeutics is planning to re-submit a BLA on omburtamab for treating patients with CNS/leptomeningeal metastases from neuroblastoma after what it characterizes as a positive pre-BLA meeting with FDA reviewers. In 10/2020, FDA issued a refuse-to-file letter on the therapy due to deficiencies
Drugs
Pfizer and BioNTech are delaying their rolling BLA for an amended Emergency Use Authorization for the Covid-19 vaccine to include children six months through four years of age. The companies, which have already submitted data on a two-dose vaccine, want to wait for further data on a studied
Devices
FDA has cleared an Esaote North America 510(k) for its Magnifico Open MRI, a whole-body MRI system intended to bridge the gap between traditional musculoskeletal imaging and whole-body imaging. It features the company’s True-Motion technology that provides real-time imaging solution of the joint, which
Drugs
FDA has granted Eli Lilly an emergency use authorization for its monoclonal antibody bebtelovimab and its use in treating Covid-19. The agency says that the therapy, which retains activity against the omicron variant, is for treating mild to moderate Covid-19 in adults and pediatric patients (12 years of
Drugs
A 2/10 Taiho Oncology petition asks FDA to impose restrictions on generic drug applicants citing Taiho’s Lonsurf (trifluridine and tipiracil) tablets for oral use as the reference-listed drug. Specifically, the petition asks FDA to: * refuse to approve any ANDA for generic trifluridine and tipiracil tablets that relies
Drugs
Ardelyx says it received 2/4 an appeal denied letter (ADL) from the FDA Office of Cardiology, Hematology, Endocrinology, and Nephrology, and will appeal that decision to the Office of New Drugs. In an SEC filing, the company says it had submitted a formal dispute resolution request early in 12/