Diagnostics: Page 56
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EU device group clarifies incoming database requirements
The publication of the guidelines comes as Europe races to be ready for the implementation of new medical device regulations.
By Nick Paul Taylor • April 16, 2019 -
J&J wins FDA OK for first targeted therapy in bladder cancer
The agency also approved a companion diagnostic from Qiagen designed to test alterations in FGFR, which are targeted by first-of-its-kind drug Balversa.
By Ned Pagliarulo • April 12, 2019 -
LabCorp partners with Qiagen to speed launch of companion diagnostics
The collaboration leverages ​Qiagen's lab program for newly approved cancer drugs and targeted IVDs.
By Meg Bryant • April 5, 2019 -
FDA serves warning letter to Virginia lab over pharmacogenetic claims
The reprimand to Inova Genomics Laboratory comes as Congress considers granting the agency more authority to regulate laboratory developed tests.
By David Lim • April 5, 2019 -
CMS to tackle lab payments codes in pair of public meetings
The agency will meet on June 24 to hear comments on setting payment amounts for codes being considered under the Clinical Laboratory Fee Schedule for 2020.
By Susan Kelly • April 1, 2019 -
FDA finalizes rules for anthrax bacteria tests, spine devices
Both devices have been classified as Class II, with special controls, and will continue to require a 510(k) premarket notification.
By Susan Kelly • April 1, 2019 -
FDA seeks to step up mammography oversight, info sharing
A new rule would standardize how facilities are required to inform patients of their breast tissue density, which can impact imaging efficacy and overall breast cancer risk.
By Maria Rachal • March 28, 2019 -
Grassley slams Verma over lab overpayment answers
CMS Administrator Seema Verma acknowledged the agency relied on maximum payment rates as a baseline for the clinical laboratory fee schedule rather than average rates.
By David Lim • March 27, 2019 -
CMS set to reopen controversial cancer test policy
The potential reassessment follows accusations of "significant policy overreach" by CMS amid concerns the policy could stop early-stage cancer patients from accessing next generation sequencing tests.
By Nick Paul Taylor • March 27, 2019 -
LifeScan dominates Medicare diabetes test strip market, OIG finds
The analysis found LifeScan's OneTouch Ultra held 29% of the non-mail order market, more than twice as much as its nearest rival.
By Nick Paul Taylor • March 26, 2019 -
Biomagnetic imaging for chest pain wins FDA clearance
The rapid, noninvasive imaging test from Genetesis, a Mason, Ohio-based startup, measures the magnetic fields produced by the heart’s electrical activity.
By Susan Kelly • March 25, 2019 -
Not even money prods patients to mail-in colon tests, study suggests
The fecal immunochemical test is used to find small amounts of blood in the stool that could be a sign of cancer or polyps.
By Susan Kelly • March 25, 2019 -
Illumina-backed study finds limited role for liquid biopsy in lung cancer
The "modest" true positive rate achieved by the blood test may limit its usefulness.
By Nick Paul Taylor • March 21, 2019 -
UK steps up no-deal planning as Brexit clock ticks down
MHRA updated its advice on registering devices against a backdrop of concerns about supply disruptions.
By Nick Paul Taylor • March 21, 2019 -
Lab industry pushes CMS to withdraw 'highly disruptive' coding changes
Nine trade groups called for reversal of certain lab and pathology section updates to National Correct Coding Initiative policy manuals.
By Nick Paul Taylor • March 20, 2019 -
Abbott gets CE mark for molecular diagnostics machine
The device expands the company's fast-selling portfolio of Alinity laboratory testing instruments.
By Nick Paul Taylor • March 20, 2019 -
Analysts tip UnitedHealth's preferred lab network to boost LabCorp, Quest
The big insurer will create a subgroup of lower-cost providers, which may help the lab giants win business from less-efficient competitors, according to investment bank Jefferies.
By Nick Paul Taylor • March 19, 2019 -
Breast implants, metal hips and other device materials under new FDA scrutiny
Symptoms such as fatigue, rash, joint and muscle pain or weakness may not appear until years after a device is implanted, FDA said.
By David Lim • March 18, 2019 -
Navigating FDA's evolving device pathways: A primer
The agency is touting the biggest alterations to medtech approval processes in the decades since it began reviewing devices. Here's a roundup of the current regulatory framework and what's potentially changing.
By Meg Bryant • March 13, 2019 -
Omada adds connected blood pressure cuff, glucometer to health program
The devices will enable participants in the digital health platform's disease prevention and management program to collect and share data.
By Nick Paul Taylor • March 13, 2019 -
Diagnostic errors compounded by EHRs No. 1 safety fear: ECRI
"We have to recognize the limits of current technology and ensure that we have processes in place to close the loop on diagnostic tests," the medical device watchdog's William Marcella said.
By Meg Bryant • March 12, 2019 -
NCI Director Ned Sharpless to be named FDA acting commissioner
Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.
By David Lim , Maria Rachal • Updated March 12, 2019 -
NCI Director Ned Sharpless to be FDA acting commissioner
Sharpless will succeed FDA Commissioner Scott Gottlieb in early April. He has served as director of the National Cancer Institute since October 2017.
By Maria Rachal • March 12, 2019 -
23andMe to gauge Type 2 diabetes risk
The genetic testing company sees a big market opportunity in the chronic disease and argues risk is currently underscreened.
By Maria Rachal • March 11, 2019 -
Roche wins first immunotherapy approval for triple-negative breast cancer
On Monday Roche announced its Ventana PD-L1 Assay was approved as the first companion diagnostic to identify triple-negative breast cancer patients for the Tecentriq-Abraxane combination.
By Ned Pagliarulo • Updated March 11, 2019
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