Diagnostics
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Courtesy of Siemens Healthineers
Siemens Healthineers' diagnostic sales soar on EU demand for COVID-19 tests
Antigen test revenue grew more than 200% but is now expected to drop significantly. Unlike rivals Abbott and Quidel, which have seen fast-falling sales, the German medtech primarily serves Europe.
By Nick Paul Taylor • July 30, 2021 -
Thermo Fisher slashes COVID-19 testing guidance by $900M
Following peers like Abbott and Quidel, execs expect test demand to slow for the rest of the year. CFO Stephen Williamson called it "prudent" to "de-risk the outlook" for testing.
By Greg Slabodkin • July 28, 2021 -
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Adeline Kon/MedTech Dive
TrendlineHow medtechs are navigating the sales environment after the pandemic
The impact of the pandemic on the industry was far from even, given the diversity of companies in the space — from those that make heart valves to artificial hips and knees to robotics to point of care testing.
By MedTech Dive staff -
Permission granted by Quidel Corporation
Quidel to transfer heart failure assay to Beckman Coulter to end litigation
While analysts at Craig-Hallum and William Blair said that they thought Quidel had a solid legal case, the agreement eliminates the remaining risk.
By Nick Paul Taylor • July 27, 2021 -
GE Healthcare's COVID-19 recovery continues with double-digit growth in imaging, ultrasound
Second-quarter results reflect the return of elective procedures to pre-pandemic levels. A standout was its pharmaceutical diagnostics business which saw orders grow nearly 50% organically year over year.
By Greg Slabodkin • July 27, 2021 -
Adobe Stock
PerkinElmer inks $5.3B takeover of antibody provider BioLegend
Flush with revenue from COVID-19 testing, the medtech is betting the company can sustain a high growth rate amid competition from BD and Thermo Fisher.
By Nick Paul Taylor • July 27, 2021 -
Philips Q2 hit from sleep apnea, ventilator recall overshadows pandemic recovery
CEO Frans van Houten downplayed the potential of a significant impact on Philips' business. But, Baird analysts contend the company could lose about $800 million in the 12-month repair/replace cycle, with ResMed benefiting.
By Nick Paul Taylor • July 26, 2021 -
Illumina-Grail merger subject of in-depth EU antitrust probe
European officials opened a three-month investigation of the deal, valued up to $8 billion, due to concerns it may reduce competition in the emerging liquid biopsy market. Illumina vowed to press on.
By Nick Paul Taylor • July 23, 2021 -
Courtesy of Abbott
Abbott latest to report pandemic recovery in Q2 as procedures return, COVID-19 tests drag diagnostics
While growth was positive across the four major businesses, coronavirus test sales came in at $1.3 billion, far below the $2.2 billion reported in the previous quarter, though ahead of lowered expectations.
By Greg Slabodkin • July 22, 2021 -
Win McNamee via Getty Images
FDA seeks funds, powers to fix 'great weaknesses' in medical device supply chain
Acting FDA Commissioner Janet Woodcock wants Congress to give the agency "expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage."
By Nick Paul Taylor • July 22, 2021 -
Getty / Edited by BioPharma Dive
PacBio inks $800M Omniome buyout to expand into short-read sequencing
The acquisition will give Pacific Biosciences access to early-stage cancer screening and recurrence monitoring markets. The bid comes 18 months after Illumina scrapped plans to acquire PacBio amid regulatory pushback.
By Nick Paul Taylor • July 21, 2021 -
Spencer Platt via Getty Images
Abbott, Intuitive and J&J kick off medtech earnings as COVID-19 bellwethers
Intuitive and J&J are set to report results this week that will shed light on the recovery of elective procedures, while Abbott will provide insights into the drop in coronavirus test demand.
By Nick Paul Taylor • July 19, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
FDA grants Curative request to revoke COVID-19 test EUA, company pivots to Abbott kits after false result risk
The agency, which announced the revocation on Thursday, originally granted an emergency use authorization to Curative's test in April 2020. By January, FDA had concerns about false results potentially linked to sample collection.
By Nick Paul Taylor • July 16, 2021 -
Courtesy of Qiagen
Qiagen joins Abbott, Quidel cutting 2021 outlook as COVID-19 test demand wanes
CEO Thierry Bernard blamed a faster-than-expected testing drop and uptick of vaccinations. Jefferies said the downgraded targets are disappointing, particularly given management's forecast reiteration last month.
By Greg Slabodkin • July 13, 2021 -
Sarah Silbiger via Getty Images
MDUFA talks expose 'fundamentally different' views of FDA and device companies
At the latest meeting over user fees, industry remained opposed to the agency's pitch for a Total Product Life Cycle Advisory Program, which it contends would extend the scope beyond FDA's purview.
By Nick Paul Taylor • July 12, 2021 -
Courtesy of Abbott
Abbott lays off 400 workers amid drop in demand for COVID-19 tests
The company cut its 2021 outlook in June, blaming a sharp, rapid decline in demand for its coronavirus-related diagnostics on global vaccination efforts. The downward trend is anticipated to continue, an Abbott spokesperson said.
By Greg Slabodkin • July 09, 2021 -
Permission granted by Quidel Corporation
Quidel COVID-19 PCR recall dubbed Class I by FDA due to false negative risk
The diagnostic company said it worked with FDA to confirm "a rare potential" for false test results and that the notice alerts lab customers of label changes made two months ago with no products removed from shelves.
By Nick Paul Taylor • UPDATED: July 9, 2021 at 8:57 a.m. -
As EU-wide health technology oversight law nears passage, industry is not pleased
If passed, the legislation mandates European Union clinical assessments of certain medical devices to inform national-level pricing and reimbursement decisions.
By Nick Paul Taylor • July 06, 2021 -
Sarah Silbiger via Getty Images
Neuromodulation and cancer devices feature in latest batch of FDA breakthrough nods
Neuroelectrics, Neuros Medical and Onward are among those that secured the regulatory privilege, which speeds the review process for unmet medical needs.
By Nick Paul Taylor • July 02, 2021 -
Sarah Silbiger via Getty Images
PMA apps could hit record in 2021, pressuring a pandemic-stressed FDA
Despite increased workloads from the coronavirus crisis, the agency is also on track to issue record numbers of safety warnings and letters to healthcare providers in 2021, according to a Wells Fargo analysis.
By Nick Paul Taylor • July 02, 2021 -
Abbott
COVID-19 antigen testing on par with PCR when used often: NIH-funded study
The two diagnostic methods were equally effective in detecting SARS-CoV-2 infection. The results could be good news for antigen test makers Abbott, Becton Dickinson and Quidel.
By Greg Slabodkin • July 01, 2021 -
Courtesy of Abbott
Abbott gets CE mark to sell COVID-19 antigen test directly to consumers in Europe
The company's rapid Panbio diagnostic received the marking in January for asymptomatic coronavirus screening. However, the test missed half of COVID-19 cases in people without symptoms, according to a recent Irish study.
By Greg Slabodkin • June 28, 2021 -
Permission granted by E.A. Crunden
Lawmakers reintroduce diagnostic regulation bill that split the industry
The VALID Act would create a risk-based regulatory framework for in vitro diagnostics and laboratory-developed tests. ACLA, whose members include Quest and LabCorp, is reviewing the bill but has objected to earlier drafts.
By Nick Paul Taylor • June 25, 2021 -
EU clarifies Eudamed rules for legacy and custom-made devices
The Medical Device Coordination Group has provided information on products placed on the market under frameworks other than MDR and IVDR, which the advisers said should be registered in the database.
By Nick Paul Taylor • June 25, 2021 -
Danielle Ternes/MedTech Dive
PerkinElmer, Qiagen latest medtechs to target rapidly growing CRISPR market
Qiagen launched new products to enable researchers to better analyze the gene editing impact of their work, while PerkinElmer bought viral vector gene delivery company SIRION Biotech to complement its CRISPR portfolio.
By Greg Slabodkin • June 23, 2021 -
Courtesy of Siemens Healthineers
UnitedHealthcare skimping on COVID-19 test pay: California doctors group
The California Medical Association says UnitedHealthcare still is not covering the cost of all COVID-19 diagnostic testing, despite state and federal guidelines that require the services to be provided at no cost to patients.
By Susan Kelly • June 21, 2021
