Fierce Medical Devices

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Updated: 5 hours 21 min ago

Battelle deploys decontamination system for reusing N95 masks

11 hours 12 min ago
Battelle received an emergency go-ahead from the FDA over the weekend to deploy its decontamination system for personal protective equipment, allowing healthcare workers to clean and reuse scarce N95 respirator masks.

Not so fast using CPAPs in place of ventilators. They could spread the coronavirus

12 hours 4 min ago
The limited supply of ventilators is one of the chief concerns facing hospitals as they prepare for more COVID-19 cases. In Italy, where hospitals have been overwhelmed with patients in respiratory failure, doctors have had to make difficult life-or-death decisions about who gets a ventilator and who does not.

ACC: 10-year coronary stent outcomes similar to bypass surgery, but less durable

Sun, 03/29/2020 - 09:48
In one of the longest studies to date in high-risk heart disease, researchers found no significant difference in death rates over more than 10 years—as well as in cases of heart attack or stroke—between people that had received a drug-eluting stent for their blocked coronary artery compared with those who underwent standard bypass surgery.

ACC: Medtronic's renal denervation study returns, showing drops in stubbornly high blood pressure

Sun, 03/29/2020 - 07:51
Medtronic is back with new data finally demonstrating the effectiveness of its catheter-based ablation procedure aimed at the kidneys to help lower high blood pressure where multiple medications have failed.

ACC: Edwards’ TAVR safety study holds equal to open surgery after 2 years in low-risk patients

Sun, 03/29/2020 - 05:19
In 2019, Edwards Lifesciences presented data showing that patients undergoing less-invasive, transcatheter aortic valve replacement procedures performed better after one year compared to those who had had open heart surgery. That study continues, and now—at the two-year mark—the data indicates that both sets of patients fare equally well when it comes to risks of stroke, hospitalization and death.

Abbott to ship portable, 5-minute coronavirus tests nationwide

Sat, 03/28/2020 - 10:14
Abbott is launching a rapid coronavirus test able to deliver positive results in as little as five minutes, from a table-top box the size of a small toaster oven.

U.S. agencies to collaborate on wide-scale 3D printing of ventilator parts and medical supplies

Fri, 03/27/2020 - 08:01
Demand for critical medical supplies continues to rise, as does the number of COVID-19 cases, and 3D printers have been seen as a way to help bolster manufacturing capabilities, wherever it is needed. Now, the FDA will be working with government and public-private partners to distribute and evaluate 3D designs and models, in a bid to provide desperately needed hardware and parts.

FDA authorizes CPAP machines and more as emergency ventilator alternatives

Thu, 03/26/2020 - 10:59
The FDA issued a wide-ranging emergency policy allowing alternative devices to be used as potentially lifesaving ventilators as shortages begin to impact hospitals’ responses to the coronavirus pandemic.

Pear Therapeutics nets digital pre-cert clearance for its insomnia-treating app

Thu, 03/26/2020 - 07:45
Expanding the reach of its digital therapeutic programs from substance abuse disorders to insomnia, Pear Therapeutics has received a new FDA clearance for its neurobehavioral app aimed at chronic sleeplessness.

FDA warns of premature EpiPen auto-injector activations

Wed, 03/25/2020 - 08:14
The FDA warned patients, parents and providers that various EpiPen models could malfunction and spring their needles early.

FDA to allow COVID-19 treatments with blood from survivors

Wed, 03/25/2020 - 07:16
The FDA unlocked the use of convalescent plasma—derived from the donated blood of people that have recovered from COVID-19 and which may contain helpful antibodies—as an investigational treatment for patients with severe cases of the disease.

Ford details 'scrappy and creative' plans to boost medical equipment production with 3M, GE

Tue, 03/24/2020 - 11:31
Ford Motor Company has outlined plans to re-task some of its manufacturing lines toward the production of much-needed medical equipment including protective face masks, personal air-filtering equipment and ventilator systems for intensive care units.

FDA authorizes hand-held COVID-19 diagnostic test

Tue, 03/24/2020 - 07:13
Mesa Biotech’s palm-sized Accula device is designed to enable near-patient testing, available anywhere outside of the laboratory, with results in about 30 minutes.

Roche CEO Schwan says COVID-19 diagnostics still aren't meeting sky-high demand: CNBC

Mon, 03/23/2020 - 12:12
Since its coronavirus diagnostic received the first emergency green light from the FDA 10 days ago, Roche has delivered over 400,000 kits to laboratories across the U.S.—but CEO Severin Schwan said it could take weeks or even months for the industry as a whole to catch up to the widespread need for testing.

Eli Lilly offers drive-thru COVID-19 testing to Indianapolis docs, nurses

Mon, 03/23/2020 - 08:17
Eli Lilly detailed its plans to offer drive-through COVID-19 testing out of its Indianapolis headquarters—starting today for healthcare providers within the community.

Trump, FDA turn to automakers to boost ventilator production

Mon, 03/23/2020 - 07:26
The FDA is temporarily waiving its enforcement and inspection requirements to allow companies outside the healthcare industry—such as automakers and other manufacturers—to begin fabricating much-needed parts for ventilators and other respiratory hardware.

FDA clamps down on at-home coronavirus testing, citing fake products and bad actors

Sat, 03/21/2020 - 11:20
As the agency combats genuinely fake tests being shipped to the U.S. from overseas, telehealth companies just starting to offer home-based kits could be facing new hurdles.

FDA greenlights first 45-min, point-of-care coronavirus diagnostic test

Sat, 03/21/2020 - 09:49
The FDA has authorized its first rapid, point-of-care diagnostic for the novel coronavirus—allowing physicians in hospitals, clinics and emergency rooms to test a sample for the disease in about 45 minutes.

FDA looks to expand remote monitoring to free up hospital space

Fri, 03/20/2020 - 11:52
Shortly after telling researchers to go virtual to keep their clinical studies going, the FDA has issued a new policy giving manufacturers some leeway in marketing their remote vital-sign-measuring devices.

FDA opens up Bellerophon’s gas therapy for COVID-19, stock rockets

Fri, 03/20/2020 - 07:13
Using a regulatory pathway that allows patients with life-threatening conditions to use unapproved therapies, the FDA has granted “emergency expanded access” to Bellerophon Therapeutics’ inhaled nitric oxide delivery system for treating the novel coronavirus.