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U.S. FDA headquarters

Questions regarding particulate matter pepper docket for FDA’s atherectomy draft guidance

Oct. 26, 2020
By Mark McCarty
The U.S. FDA draft guidance for select updates for premarket evaluation of class II atherectomy devices arrived with a lack of clarity that prompted device makers and clinicians alike to request the FDA address several sources of ambiguity. One of these is whether the agency should distinguish between particulate matter from the device vs. calcium particulates from the treated artery, while another is whether particulate evaluation is required only for devices with a coating.
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U.S. flag on columned building

Violations of Anti-Kickback Statute the primary driver of U.S. DOJ enforcement in FY 2019

Oct. 23, 2020
By Mark McCarty
Drug and medical device manufacturers have several compliance matters to deal with under the False Claims Act (FCA), only one of which is the Anti-Kickback Statute (AKS). Nonetheless, the AKS might be a good area for members of industry to emphasize, given that it accounted for the vast majority of federal enforcement actions in fiscal year (FY) 2019, according to a new report by Gibson, Dunn & Crutcher LLP.
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Doctor, patient, computer

Patients keen on taking part earlier in SaMD development process

Oct. 22, 2020
By Mark McCarty
Patient engagement is increasingly the order of the day in the device development process as the U.S. FDA has made clear, a consideration that drove the Oct. 22 FDA advisory hearing. A patient representative said patients want to take part as early as possible in the development process for software as a medical device (SaMD), and Pat Baird, director of global software standards for Royal Pillips NV, said industry is very much open to ideas about bringing the patient perspective on board earlier in that process.
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U.S. vaccine illustration

Confidence still lacking in future COVID-19 vaccines

Oct. 22, 2020
By Mari Serebrov
With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA-approved products. That message was drummed home throughout the Oct. 22 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
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Appliedvr product image

Appliedvr scores breakthrough status for pain therapy

Oct. 21, 2020
By Meg Bryant
Digital medicine startup Appliedvr Inc. has gained breakthrough device designation status from the U.S. FDA for its virtual reality (VR) platform for treating treatment-resistant fibromyalgia and chronic intractable lower back pain. The designation follows the completion of a clinical trial assessing VR-based therapy for self-management of chronic pain at home.
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FDA vaccine illustration

FDA staging vaccine adcom as PR event

Oct. 21, 2020
By Mari Serebrov
While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization.
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Product image

Philips launches new mechanical thrombectomy system for removing blood clots

Oct. 19, 2020
By Bernard Banga
Royal Philips NV is launching its Quickclear mechanical thrombectomy system in the U.S. four months after obtaining FDA clearance. “Quickclear's intuitive design simplifies the entire thrombectomy procedure work flow. Our new medical device can help bring cost-effective solutions in both the hospital and outpatient care settings,” Chris Landon, senior vice president & business leader, image guided therapy devices at Philips, told BioWorld.
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Rotea system next to tablet

Thermo Fisher introduces modular, closed cell processing system

Oct. 15, 2020
By Annette Boyle
Thermo Fisher Scientific Inc. launched a new cell therapy processing system that overcomes many of the hurdles that have kept promising cell therapies from reaching commercialization. The modular, closed system increases cell processing efficiency and reduces associated costs.
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3D heart in chest

Spectrawave taps new CEO to lead development of cardiac imaging system

Oct. 14, 2020
By Mary Ellen Schneider
Spectrawave Inc. has named Eman Namati as its CEO with the charge of commercializing its flagship cardiac imaging technology. The 3-year-old, Bedford, Mass.-based medical imaging company has set an ambitious 24-month timeline for getting its photonic imaging technology for coronary artery disease into the clinic.
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U.S. Supreme Court

Supreme Court grants cert to three iterations of Arthrex appointments question

Oct. 13, 2020
By Mark McCarty
The case of Arthrex v. Smith & Nephew at the U.S. Court of Appeals for the Federal Circuit was something of a nuclear option for the patent dispute at hand, as it raised a constitutional question regarding the appointment of administrative patent judges (APJ) at the Patent Trial and Appeal Board (PTAB). The Supreme Court has agreed to hear a consolidation of three petitions for cert arising from the Arthrex case, the outcome of which could force the reopening of a number of cases already decided by the PTAB.
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