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CMS to cover Abbott’s glucose monitoring device

Abbott Laboratories said its newly launched glucose monitoring device would be covered by the Centers for Medicare & Medicaid Services, expanding its usage to millions of diabetes patients in the United States.

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FDA issues recall on J&J heart device

The U.S. Food and Drug Administration issued a recall of a heart device made by a unit of Johnson & Johnson due to a faulty valve.

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Starting new COPD inhaler tied to heart attack risk

People with chronic obstructive pulmonary disease (COPD) who use long-acting inhaled bronchodilators may have an increased risk of heart attacks and strokes right after they start taking these medicines, a Taiwanese study suggests.

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Four Top-Performing S&P 500 Biotech Stocks of 2017

Todd Campbell, writing for The Motley Fool, notes four biopharma stocks that topped out in the S&P 500 in 2017.

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Anika Announces FDA 510(k) Clearance for Injectable HA-Based Bone Repair Treatment

Anika Therapeutics Inc. announced that its HA-based bone void filler received 510(k) clearance from the U.S. FDA and is indicated for filling bone voids or defects of the skeletal system, which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury.

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U.S. FDA plans to let device makers report malfunctions less frequently

The U.S. Food and Drug Administration said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problems.

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Medtronic settles states’ probe into Infuse marketing for $12 million

Medtronic Plc agreed to pay $12 million to resolve claims that the company engaged in a deceptive marketing strategy to promote its Infuse bone graft product used in spinal surgery, the Massachusetts attorney general said.

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Republicans propose to delay, pause Obamacare taxes

U.S. House Republicans proposed to delay or suspend several taxes under former President Barack Obama’s healthcare law, including a tax on medical devices and the so-called “Cadillac” tax on generous health insurance plans.

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Nine Biotechs Facing FDA Decisions in December 2017

The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.

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FDA Clears First Medical Device Accessory for Apple Watch

AliveCor today announced FDA clearance of KardiaBand in the U.S., allowing Apple Watch users to discreetly capture their EKG anytime and anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia.

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Cochlear obtains FDA approval for first remote programming option for cochlear implants

Cochlear Limited received U.S. Food and Drug Administration approval for the first remote feature to allow follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.

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FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients

The U.S. Food and Drug Administration approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.

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U.S. FDA approves first two-drug HIV regimen in win for GSK

The U.S. Food and Drug Administration approved the first two-drug regimen to treat HIV, aimed at lessening the side effect burden of current treatments that combine three or four medicines.

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J&J hit with $247 million verdict in hip implant trial

A federal jury in Dallas ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay $247 million to six patients who said they were injured by defective Pinnacle hip implants.

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Merit Medical Coughs Up $100 Million for Bard, BD’s Biopsy Assets

Shares of Merit Medical Systems jumped more than 9 percent after the company announced it plunked down $100 million for two product lines belonging to Becton, Dickinson and Company (BD).

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Europe approves GSK’s new triple lung drug

The European Commission approved GlaxoSmithKline’s three-in-one inhaler Trelegy Ellipta for chronic lung disease.

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FDA clears nerve stimulator for opioid withdrawal symptoms

The FDA approved an electrical nerve stimulator designed to reduce the symptoms of opioid withdrawal.

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U.S. approves digital pill that tracks when patients take it

U.S. regulators approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.

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Global Med Device Leader Anthrex Reveals Big Expansion Plans

Less than one month after announcing plans for construction of a South Carolina manufacturing facility, surgical solutions firm Arthrex announced the company’s plans for the expansion of its global headquarters in Florida.

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Philips sees 4-6 percent sales growth in health technology push

Philips expects sales to grow by 4-to-6 percent in the coming three years as the Dutch company focuses on growth in the health technology market.

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