Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 32 n° 302

Posts Tagged ‘Medical device’

Veeva Announces Medical Device & Diagnostics Summit 2020

Posted by fidest press agency su sabato, 14 settembre 2019

Veeva Systems (NYSE:VEEV) will host the 2020 Medical Device & Diagnostics Summit June 1-2, 2020 in Minneapolis. Industry experts from the world’s most innovative medical device companies will share best practices to shorten the product development lifecycle and keep pace with evolving regulations such as MDR.“Veeva is committed to helping the industry improve speed and agility across product development,” said Jim Diefenbach, general manager of medical device and diagnostics at Veeva. “We’re excited to bring the medical device and diagnostics community together to advance how the industry gets products to market and stays ahead of global compliance requirements.”More than 70 medical device and diagnostics companies, including 8 of the 10 largest, now use applications from Veeva Vault Medical Device Suite. Attendees at Veeva Medical Device & Diagnostics Summit will discuss opportunities in commercial, clinical, quality, and regulatory.

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CynergisTek Sees Increased Demand for Medical Device Security Services in First Year of Deployment

Posted by fidest press agency su domenica, 11 agosto 2019

CynergisTek, Inc., (NYSE AMERICAN: CTEK), a leader in healthcare cybersecurity, privacy, and compliance, today announced that it has experienced significant market demand with Medical Device Security Service customer wins at leading health systems since launching the service in late 2018. Sixty percent of the contracts were existing Compliance Assist Partner Program (CAPP) clients that expanded their relationship with CynergisTek to add ongoing Medical Device Security Service engagements. In a recent survey, nearly one-third of healthcare executives reported that medical device security is one of the top five cyber risks facing healthcare today, however the majority also reported not having an effective (or any) strategy in place to assess the risks posed by medical devices. This is often due to the organization’s lack of internal resources, leaving the cyber threat to hospital operations and patient safety at an all-time high. It is for this reason that multiple leading health systems, including Banner Health, one of the largest nonprofit healthcare systems in the U.S., and Gwinnett Medical Center, one of the largest healthcare networks in Atlanta and nationally recognized for clinical excellence, have turned to CynergisTek’s Medical Device Security Service to help address security vulnerabilities by developing and managing a security strategy around its devices.
CynergisTek’s Medical Device Managed Services address the security of the entire medical device lifecycle, including policy development, pre-acquisition procedures, implementation and security control setup, identifying and reporting vulnerabilities and coordinating remediation in conjunction with the device maintenance schedule. CynergisTek’s team of security experts act as advisors, providing a comprehensive view of the system and a systematic approach to address issues or concerns during any part of the lifecycle process, whether that be alerts of a critical recall or performing risk assessments of the device and manufacturer during vendor selection.CynergisTek offers a comprehensive set of medical device services to ensure security best practices for the planning, implementation, and ongoing maintenance of an organization’s biomedical device lifecycle management program. From device acquisition to retirement, CynergisTek’s managed service program provides services to support program implementation and optimization activities as well as ongoing support to ensure a continued focus on addressing new biomedical device vulnerabilities and risks as they are discovered.

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Factory CRO Acquires MileStone Research Organization, Builds North American Presence

Posted by fidest press agency su sabato, 28 ottobre 2017

austin texasAustin (Texas) Factory CRO, a leading global contract research organization focused on medical devices and IVDs, has announced the acquisition of MileStone Research Organization. MileStone, located in San Diego, specializes in clinical research and reimbursement solutions for the medical device and biologics industries.“The merger with MileStone is an important step in building Factory’s operational strength and service range in North America,” said Dirk Meijer, M.D., Ph.D., Factory CEO. “MileStone is an excellent fit therapeutically, as well as culturally, and complements our existing U.S. operations in Austin, Texas, and Princeton, N.J. Milestone’s extensive expertise in orthopedics, neurological and IVD clinical trials, as well as their reimbursement and site management service offerings, is a fantastic value-add for all our clients.”“The combination of Factory and MileStone is good for everyone,” said Kevin Liang, Ph.D., founder of MileStone Research Organization. “Our specialization in clinical and regulatory affairs, as well as reimbursement for innovative technologies, aligns us perfectly with Factory. Factory’s full-service clinical offerings and extensive knowledge of the European regulatory environment will greatly expand our reach. The mutual commitment of both organizations to provide world-class solutions and superior client support will continue to motivate the company’s growth moving forward.”Factory performs safety, efficacy and clinical economics studies as well as quality-of-life and post-marketing studies globally for medical device, IVD and drug-device combination products. Since 1992, the company has completed more than 450 projects in Class II and III medical devices in a wide range of therapeutic areas for some of the top global medical device manufacturers.

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Gli italiani non amano le aziende del farmaco

Posted by fidest press agency su giovedì, 5 settembre 2013

Milano. Gli internauti italiani sembrano non amare le aziende farmaceutiche. Tra blog, social network, conversazioni sui Forum e search sui principali motori di ricerca, il web di casa nostra non mostra particolare affezione né per i produttori di farmaci né per le aziende di Medical Device: gli italiani, in rete, ne parlano poco, rispetto ad altri comparti industriali, ma soprattutto ne parlano male. È quanto emerge da un’indagine esclusiva, svolta tra gennaio e giugno 2013, dal mensile AboutPharma and Medical Devices in collaborazione con Netscreening, società specializzata nelle analisi di web reputation.
La ricerca appare sul numero di settembre del periodico edito da Hps – un’anticipazione dei risultati è disponibile sul sito internet del mensile, aboutpharma.com – e ha messo sotto la lente il traffico online, generato in Italia, riguardante 70 aziende farmaceutiche (italiane e straniere) e i principali produttori di dispositivi medici, selezionandone una quarantina tra quelli che presentavano la maggiore significatività statistica. Le aziende farmaceutiche sono state “analizzate” utilizzando il rispettivo brand come parola chiave.
La ricerca di AboutPharma e Netscreening ha rilevato che gli italiani, in rete, parlano pochissimo delle farmaceutiche: fatto cento il valore attribuito alle tendenze di ricerca dedicate al sistema industriale nel suo complesso, l’azienda Pharma che totalizza più “search” (Pfizer) è ben ultima, con indice 2, dietro a brand quali Samsung (88), Ikea (41), Fiat (28) e Kinder (4). Il tutto a dimostrazione che il posizionamento delle aziende del farmaco nei dibattiti on-line è poco significativo se confrontato con altri segmenti merceologici.Inoltre dall’analisi del “sentiment” sul segmento Pharma e Medical Device che emerge dalle discussioni via internet degli utenti italiani, risulta che in rete si dialoga di farmaci e dispositivi medici con atteggiamento per lo più neutro e distaccato (64%). Chi invece manifesta sul web emozioni più definite, non sembra provare grande affezione verso i produttori di farmaci: le manifestazioni di “sentimento negativo” si attestano al 27,6%. Meno “indigesto” il mondo dei dispositivi, con il 76,7% delle discussioni dal tono neutro e un sostanziale pareggio fra giudizi negativi e positivi (rispettivamente 13,25% e 10,05%).Con riguardo ai singoli brand, Pfizer guida la classifica della presenza sul web, con 4.578 discussioni (seguono Bayer e Novartis, notevolmente distanziate); Baxter, invece, si aggiudica il primo posto tra le aziende di Medical Device, ma bisogna tener presente che produce anche farmaci e l’indagine sulla ricorrenza del marchio non può tener conto della doppia veste produttiva.Inoltre determinati fatti specifici (uno scandalo internazionale, un’azione della magistratura oppure un “caso” terapeutico) mostrano tutta la loro capacità di incidere negativamente sulla percezione di brand, determinando così in molti casi una reputazione negativa dell’azienda in questione.La ricerca di AboutPharma è arricchita da commenti di osservatori ed esperti del mondo della comunicazione, da Alberto Contri (Pubblicità progresso) a Mario Pappagallo (Corriere della Sera) e il suggerimento è pressoché univoco: il comparto farmaceutico deve adeguarsi a nuove responsabilità e nuovi linguaggi. Il web, insomma, non può lasciare indifferenti. Soprattutto se tocca la reputazione aziendale.

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Sindrome coronarica: con angioTac dimissioni più sicure

Posted by fidest press agency su lunedì, 30 aprile 2012

Nei reparti di emergenza – dove è elevato il numero di ricoveri per sospette sindromi coronariche – l’impiego dell’angioTac, dall’alto potere predittivo negativo, nei soggetti a basso-medio rischio aumenta le dimissioni sicure. La strategia, messa a punto per verificare rapidamente se il dolore del paziente sia di origine cardiaca o meno, è stato ideato e sperimentato con successo in un trial multicentrico da una task-force di radiologi e cardiologi interventisti statunitensi coordinata da Harold I. Litt, della University of Pennsylvania. I clinici hanno assegnato in modo randomizzato, e in proporzione 2:1, 1.370 pazienti presentatisi nel dipartimento di emergenza con i sintomi di una possibile sindrome coronarica acuta in due gruppi: il primo (n=908) avviato all’esecuzione di un’angioTac, il secondo (n=462) a ricevere un’assistenza tradizionale. Su 640 pazienti che hanno effettuato un esame angioTac con esito negativo, nessuno è morto o ha subito un infarto miocardico entro 30 giorni (outcome primario di sicurezza). Rispetto ai pazienti sottoposti a cure standard, il gruppoo angioTac ha fatto registrare un tasso più elevato di dimissioni dal dipartimento (49,6% vs 22,7%), un tempo inferiore di degenza (in media: 18 ore vs 24,8) e una quota maggiore di identificazioni di malattie coronariche (9% vs 3,5%). N Engl J Med, 2012; 366(15):1393-403 (fonte: doctornews33)

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Westhouse Medical Services Plc Seeks to Expand Into US Market by Entering Negotiations

Posted by fidest press agency su venerdì, 9 marzo 2012

English: Acute angle closure glaucoma of the r...

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London, (PRNewswire)Glaucoma specialist will expand Westhouse Medical Services portfolio and allow access to US marketHealthcare specialist Westhouse Medical Services Plc (“Ticker Symbol 5WM”) today announces it is entering into negotiations for the acquisition of a majority control of US listed Sunridge International. Sunridge’s subsidiary, Ophthalmic International Inc., has developed a glaucoma procedure called PNT, which could revolutionise the way glaucoma is treated globally.Westhouse Medical Services, listed on the Open Standard Section of the Frankfurt Stock Exchange, is aggressively implementing its expansion plans, and this acquisition will further build its medical devices subsidiary.The majority control will also provide Westhouse Medical Services with access to the US markets for its BreastCheck product, which is patented and FDA approved. Currently Westhouse’s medical devices subsidiary is in the process of bringing BreastCheck to market, a new non-invasive, self-administered breast cancer screening device. BreastCheck is due for launch Summer 2012.As part of this acquisition, Westhouse aims to market PNT, the only non-invasive, non-pharmaceutical approach that has been clinically proven to reduce elevated intra-ocular pressure (IOP) in patients with primary open angle Glaucoma (POAG), as well as ocular hypertension (OH). POAG represents 95 per cent of diagnosed cases of glaucoma in Europe, the Americas and Africa.PNT reduces the fluid pressure in the eye, decreasing or eliminating the need for drug therapy in a significant proportion of patients.
Westhouse Medical consists of two divisions – Devices and Services. This will be the second acquisition by Westhouse’s medical devices division, following the purchase of US and UK patents for the Profemme breast cancer screening technology from the Battlebridge Group Limited in November 2011. Westhouse’s other subsidiary, medical services, provides specialist transport and ambulance services for the NHS in the UK.

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