23andMe will resume providing health data following FDA setback
Following the shutdown by the FDA, 23andMe is back in business and reportedly took advantage of its two-year hiatus.
Morning Read: Novartis gets green light from FDA for heart failure drug, CVS bows out of Chamber of Commerce over tobacco
Novartis has gotten a quick FDA approval for the heart hailure drug Entresto and Aimmune is shooting for $115 in IPO for its allergy drug therapy.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Acute kidney injury diagnostic gets marketing nod from FDA
A first-of-its-kind laboratory test to gauge severe acute kidney injury has been approved for marketing by the Food and Drug Administration. Developed by San Diego’s Astute Medical, the NephroCheck test is meant to be used in critically ill, hospitalized patients. It can gauge whether a patient pool that generally consists of diabetics, the elderly and those […]
FDA approval for drug for Peyronie’s disease adds alternative to surgery
The U.S. Food and Drug Administration’s approval of Auxilium Pharmaceuticals’ drug Xiaflex (NASDAQ: AUXL) makes it the first medication to treat Peyronie’s disease. It is a painful condition affecting the penis and the drug could lead to more people seeking treatment. Peyronie’s disease is a connective tissue disorder that results in the growth of fibrous plaque […]
The future of noninvasive glucose meters? I-Pod sized and ear-clipped
The healthcare startups in the race to launch an approved noninvasive, bloodless glucose meter for the growing diabetes patient population is on. While each company etches out its value proposition and aims for commercial launch, a look at what the devices with potential for success in this space have in common. What the successful breakout […]
3-D St. Jude Medical launches technology that gives docs real-time, 360-degree view of arteries
St. Jude Medical (STJ) announced FDA approval of its ILUMIEN OPTIS PCI Optimization System, and the product’s U.S. launch. The device gives physicians a real-time, 360-degree panoramic view of the arteries, to help with stent placement and to guide treatment for patients with coronary artery disease. But what’s the true value proposition between this new […]
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A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
No catheter, no cuff: FDA clears Sotera Wireless’ continuous noninvasive blood pressure technology
No more catheter, no more cuff for monitoring patient vital signs? Sotera Wireless announced the FDA has given 510(k) clearance to its continuous non-invasive blood pressure (cNIBP) technology, a new feature of its ViSi Mobile patient monitoring system. “For the first time clinicians can continuously monitor all patient vital signs, including beat-to-beat blood pressure, without the […]
FDA grants Neuros Medical IDE approval to conduct clinical trial for pain management technology for amputees
Neuros Medical, a Cleveland-based medical device company, received an FDA investigational device exemption approval to begin a clinical study on its technology for intractable limb pain management for amputees. According to the company website, the Altius System High Frequency Nerve Block technology “consists of an electrode (also known as a lead) placed around a peripheral […]
Biotronik receives FDA device approval for ‘smaller, thinner’ one-lead implantable cardiac defibrillator
Biotronik, an Oregon-based cardiovascular medical device company, announced it received final FDA device approval for its Ilesto DX, an implantable cardiac defibrillator. Earlier this year, it received FDA device approval for family of implantable cardioverter-defibrillator and cardiac resynchronization therapy defibrillators. This week’s approval is an “upgraded” device. This “smaller, thinner” new generation platform allows for a […]
Cigna chief medical officer says ‘gap of hopefulness’ separates FDA approval & reimbursement
Cost effectiveness and outcomes drive value for payers, Cigna‘s Chief Medical Officer Alan Muney said. While some medical device companies assume an FDA approval will mean a definite reimbursement nod from payers, these two forces drive a sometimes wrongheaded “gap of hopefulness” for the industry. (See his discussion of why device companies need to think […]
Maximize Revenue and Patient Care with Strategic Weight Loss Management
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
BSX gets FDA approval for ablation catheter, becomes third major player this week with ablation milestone
Boston Scientific (BSX) announced it has received U.S. Food and Drug Administration approval for its IntellaTip MiFi XP catheter and 501(k) clearance for its Zurpaz 8.5F steerable sheath, growing its EP mapping/ablation technology portfolio. This makes it the third major player–following both St. Jude Medical, which acquired Endosense, and GE, which invested in Acutus Medical–to […]
FDA approves St. Jude’s ablation catheter for MediGuide platform
EP mapping (and the catheters that go with them) continues to be a hot topic in cardiac. St. Jude Medical adds an approved ablation catheter enabled to work with its prize hen, MediGuide Technology, the EP 3-D navigation platform that “allows physician to see the exact location and orientation of devices” inside a patient’s heart […]
GI gets FDA nod for PillCam SB, plans for big Q4
The third generation of Given Imaging‘s PillCam SB got FDA approval today, and President and CEO Homi Shamir said the product should launch in October of this year. The device, a capsule with a camera inside which the patient swallows takes more than 60,000 images before it exits the digestive system. As the Israel-based continues […]
Remote health monitoring system gets FDA 510(k) clearance
Ambio Health, a Stamford, Conn.-based company that specializes in health monitoring, received a Class II FDA 510(k) clearance for its Ambio Remote Health Monitoring System. With the intent of saving patients money, the device, which includes a wireless blood glucose monitor and wireless gateway (a blood pressure meter and weight scale, also FDA-approved, can be […]
New bill may allow FDA user fees to be exempt from sequestration, i.e. used as user fees
The FDA may be freed up to put its user fees to use for product review for medical devices and drugs, if a bipartisan bill introduced in the House passes. In essence, the bill exempts the FDA user fees from sequestration and may take one burden off the already slow approval process. That adds up […]