Infervision Technology Co. Ltd. has received the green light from the U.S. FDA for its Inferread Lung CT.AI product. The artificial intelligence- and deep learning-based technology automatically performs lung segmentation and identifies and labels different types of lung nodules. According to the 510(k) notification, Inferread Lung CT.AI “is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest on an asymptomatic population.”
A first-of-its-kind clinical trial conducted by digital health startup AppliedVR suggests the computer-based technology is both feasible and effective for treating chronic pain in a patient’s own home.
Keeping you up to date on recent developments in diagnostics, including: Diagnosing fatty liver disease; Assessing COVID-19 with lung ultrasound; Noncoding mutations contribute to heart disease.
Virtual care provider Doctor On Demand has scooped up $75 million in a series D round led by General Atlantic, with participation from existing investors. The funds are earmarked to fuel the company’s growth and expand access to comprehensive telehealth services across the U.S. Combined with earlier financings, the San Francisco-based company has raised nearly $240 million to date.
Machine learning-based diagnostics startup Dascena Inc. has won the U.S. FDA’s breakthrough device designation for its Previse algorithm, which is designed to predict acute kidney injury (AKI) before clinical symptoms. In early validation tests, Previse detected AKI more than a day before patients exhibited kidney damage or impaired function.
With the push for value-based care, health care players – from manufacturers, to providers, to payers – are looking for ways to improve patient quality while reducing the costs of care. Advanced technologies, including digital health and artificial intelligence (AI)-based tools, are a major part of the equation, but companies face several challenges and barriers to adoption. To that end, management consultancy has launched a new Health Tech website featuring a Health Tech Industry Accounting Guide and other helpful advice for health-tech companies.
Keeping you up to date on recent developments in diagnostics, including: Broad scale genomic testing for childhood illness; Deep learning model for cancer prognosis; Placenta attachment theory.
Orthopedic implant startup Engage Surgical has received 510(k) clearance from the FDA for its Engage Partial Knee system, the only cementless partial knee implant available in the U.S. The company is introducing the product via a limited release to select surgical centers.
The U.S. FDA has greenlighted Ancora Heart Inc.’s IDE request to conduct the Corcinch-HF pivotal clinical trial. The study is intended to demonstrate the safety and effectiveness of the Accucinch ventricular restoration system in patients with heart failure and reduced ejection fraction (HFrEF).
Envoy Medical Corp. got some early support for its Acclaim fully implantable cochlear implant, with a breakthrough device designation from the U.S. FDA. If approved, it would be the first cochlear implant to address hearing loss without the use of any external components.
