The Latest
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Mercy expands RWE program to capture data from other providers
The expansion of the network follows real-world evidence deals with BD, Johnson & Johnson and Medtronic.
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Heart failure shunt receives FDA's breakthrough designation
J&J Innovation and Edwards Lifesciences are among investors backing development of the implant, which aims to ease pressure on the left side of the heart and reduce buildup of fluid in the lungs in advanced heart failure patients.
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Hearing industry calls Bose self-fit hearing aid study flawed in complaint to FDA
The Hearing Industries Association letter argues the device's Phase II clinical study "does not provide enough evidence of effectiveness of the self-fitting method given the study's initial reliance on professionals for fitting."
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Abbott poised to profit from CMS review of TMVR coverage
Analysts at Cowen estimate CMS coverage in a newly considered indication could triple the number of patients eligible for transcatheter mitral valve repair.
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Senators push HHS for details of response to DNA test scam
Lawmakers propose pre-claim review of genetic test orders to root out fraud.
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Industry backs Australia's device identifier plan with caveats
The responses showed broad support for a unique device identification system based on global guidelines, but the Therapeutic Goods Administration also faced some pushback from J&J and Roche.
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FDA taps Type A aortic dissection stent for breakthrough program
Ascyrus Medical's leg up from U.S. regulators follows Health Canada's approval of its device for a rare but potentially fatal condition last December and CE marking in February.
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'Unprecedented' pricing pressures on Myriad send shares plunging
The challenges for GeneSight, the company's genetic depression test, were only the beginning of its woes during the quarter.
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Analysts predict big jump in continuous glucose monitor use
Abbott and Dexcom are likely to dominate the CGM market in the long term. Medtronic is expected to remain the leader in insulin pumps.
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Two more notified bodies designated in EU, but pace still lags
The public database NANDO lists German company Dekra Certification as one of the two notified bodies.
UPDATED: Aug. 14, 2019 at 9:11 a.m. -
Stryker acquires maker of device sterilization systems
The deal comes against a backdrop of heightened regulatory scrutiny of duodenoscope reprocessing after a spike in contamination cases and the closure of a Sterigenics plant in Illinois that sterilized a wide range of devices.
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Imaging study links poorly controlled blood pressure to marker of cognitive decline
A NIH-funded imaging trial found intensive blood pressure treatment tied to reductions in lesions associated with cognitive decline.
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FDA hits medicine cabinet and cart maker Talon with warning letter
The agency found 11 violations of quality system regulations, ranging from failure to follow audit principles and perform risk analysis to inadequate procedures covering design changes and control of nonconforming products.
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USTR: 10% tariffs on 'certain' electronics from China delayed to Dec. 15
Chinese imports not included on USTR's forthcoming list will still face 10% duties on Sept. 1, as President Donald Trump announced earlier this month.
UPDATED: Aug. 13, 2019 at 3:27 p.m. -
AFib device maker AtriCure to spend up to $300M in SentreHeart buyout
AtriCure announced Tuesday it completed its acquisition of SentreHeart.
UPDATED: Aug. 14, 2019 at 9:28 a.m. -
Concept Medical nabs breakthrough designation for sirolimus-coated balloon for PAD
If granted FDA marketing authorization, the device may compete with paclitaxel devices sold by BD, Medtronic, Boston Scientific, Philips and Cook Medical.
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Australia weighs in on paclitaxel-coated balloons
The Therapeutic Goods Administration said data on adverse events in Australia haven't shown a signal like the one described by FDA.
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China grants innovative device designation to Novocure's Optune
Novocure's Chinese partner now gets the opportunity for more contact with regulators and an expedited review in a market estimated at $96.3 billion this year, up from $53.6 billion in 2016.
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CMS rejects industry bid to boost payments for device-based opioid alternatives
The agency said evidence submitted was plagued by potential conflicts of interest, inadequate sample sizes and lack of peer review.
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Ambu to pay $3.3M to settle False Claims Act allegations
The Danish medical device maker is accused of manufacturing products in China and Malaysia and knowingly selling them to U.S. government agencies in violation of the 1979 Trade Agreements Act.
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NuVasive looks to tech pipeline, overseas expansion in bid for spine market share
Some analysts think achieving revenue growth in the mid-single digits could be a challenge, given tough dynamics in the spinal surgery market.
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Blood test to detect breast cancer recurrence, guide treatment, shows promise in small study
Researchers hope the liquid biopsy test, which demonstrated high accuracy in detecting residual disease in a small study, can help breast cancer patients avoid unnecessary surgeries.
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MD Anderson taps Hitachi for $159M proton therapy expansion
The cancer center will more than double the size of its existing site to meet rising demand amid mixed messages about the viability of running proton therapy centers in the U.S.
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UBS surgeon poll points to neuromodulation market slowdown
Those surveyed predicted Medtronic would gain the most market share going forward, with Boston Scientific in second place and Abbott in third.
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Radiology societies partner with HP on 3D printing registry
Doctors hope the point-of-care data will help determine the value of turning medical images into patient-specific surgical models.
